005

Sexual Dysfunction among Women with a History of Childhood Sexual Abuse: The Role of Negative Appraisal of Genital Sexual Arousal and Sexual Shame
Pulverman, C¹; Meston, C¹
1: University of Texas at Austin, USA

Objective: Women with a history of childhood sexual abuse (CSA) are at a higher risk of sexual dysfunction and do not respond to existing treatments as well as non-abused women, suggesting there may be something unique about the presentation of sexual dysfunction in this population. For abused women, genital sensations may become paired with negative affect during the abuse. Therefore the genital arousal that arises during consensual sexual activity might remind a woman of her abuse, impairing her overall sexual response in the present. This study examined women’s appraisal of their genital sexual arousal as a potential mechanism underlying the relationship between history of CSA and sexual dysfunction.

Materials and Methods: Women with (n = 60) and without (n = 46) a history of CSA viewed a 6-minute erotic film and completed an adapted version of the Film Scale (Heiman & Rowland, 1983) by rating their genital arousal sensations on a series of affective words. Sexual function was assessed with the Female Sexual Function Index (FSFI; Rosen et al., 2000) and sexual shame was assessed with the Kyle Inventory of Sexual Shame (Kyle, 2013). A range of sexual function was reported across both groups of women (FSFI abused M = 23.84, SD = 6.21, range 7.60-34.20; FSFI non-abused M = 26.11, SD = 5.07, range 16-35.40).

Results: Negative appraisal of genital sexual arousal was significantly higher in abused women (M = 7.30) than in non-abused women (M = 5.83). In a structural equation model using abuse status as a dichotomous independent variable, negative appraisal of genital sexual arousal partially mediated the relationship between a history of abuse and FSFI total scores (X²(1) = 4.24, RMSEA = .18). Sexual shame was significantly higher in abused women (M = 71.73) than non-abused women (M = 49.64). In a structural equation model, sexual shame fully mediated the relationship between a history of abuse and FSFI total scores (X² (1) = 1.11, RMSEA = .03).

Conclusions: Both negative appraisal of genital sexual arousal and sexual shame help to explain the relationship between a history of CSA and sexual dysfunction. Mindfulness-based sex therapy has been more effective for treating sexual dysfunction in abused women than non-abused women (Brotto et al., 2012), yet the mechanisms underlying this therapy remains unclear. The current results suggest examining appraisal of genital sexual arousal as a potential mechanism of action in mindfulness-based sex therapy treatments for abused women.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

006

Predictors of Vaginal Sex during Vaginal Pain among Adolescent Women
Hensel, DJ¹; Fortenberry, JD¹
1: Indiana University School of Medicine, USA

Objectives: Vaginal pain is associated with decreased frequency of vaginal sex in adults, yet little research examines this relationship in adolescents. We used daily diaries to prospectively evaluate the emotional and behavioral factors young women’s day-to-day engagement in vaginal sex when they also report vaginal pain.

Material and Methods: Adolescent women (N=385, 14-17 years) completed prospective, partner-specific daily diaries. Two diary measures – any vaginal pain and any vaginal sex (both no/yes) – were used to construct the primary outcome variable: any vaginal sex during vaginal pain (no/yes). Emotional variables were: positive mood and negative mood [both 3-item scales], feeling in love and sexual interest (both single-item), partner support and partner negativity (both 3-item scales). Behavioural factors were: vaginal bleeding (no/yes) and recent vaginal sex during vaginal pain (past week: no/yes). Sequential logistic regression modelled the influence of daily factors on the odds (OR) of vaginal sex during vaginal pain; robust standard errors adjusted estimates for multiple within-subject diaries (Stata; all p<.05). All models controlled for age and relationship length.

Results: Participants reported vaginal pain on 2.1% (N=3422/166,781) of all diary days; 13% (439/3422) jointly involved a report of vaginal sex. Higher sexual interest (OR=2.09), higher partner support (OR=1.79) and recently having vaginal sex during vaginal pain (OR=2.19) predicted higher odds of vaginal sex with pain. Feelings of love for a partner (OR=0.82), higher positive mood (OR=0.86) and vaginal bleeding (OR=0.09) were associated with lower odds of vaginal sex and pain. Age, relationship length, negative mood and partner negativity did not predict vaginal sex.

Conclusions: Adolescent women’s decisions to participate in vaginal sex during vaginal pain are organized in conjunction with different emotional and behavioral factors. The relationships of these factors to developing sexuality has implications for ongoing support of healthy relationship development during adolescence.

Disclosure:

Work supported by industry: no.

007

Medical Student Attitudes, Knowledge, and Comfort Level Related to Patients’ Sexual Health
Ivanova, DK¹; Jones, EA¹; Clayton, AH¹
1: University of Virginia

Introduction and Objective: A crucial aspect of thorough patient care is a sexual health evaluation. A clinician’s knowledge and attitudes towards sexual health topics can limit the collection of relevant sexual history, and impact the outcome of patient care. While it is crucial that medical students are taught how to take an adequate sexual history early in their training, also important is awareness of their attitudes and comfort level discussing sexual health topics with their patients, and identification of areas for improvement. These assessments measured changes in attitudes, comfort level, and sense of knowledge related to human sexuality/sexual medicine across a longitudinal 15-month medical school experience, and informed quality improvements in the curriculum.

Materials and Methods: On-line administration of a sexual health topics assessment prior to initiation of classes (August 2014) in the first year of medical school and following the 15-month systems-based curriculum (December 2015) which includes pre-recorded lectures, in-class role-playing experiences, case-based discussions, patient panels, and senior student/provider dialogues. Aggregate change in medical students’ responses reflecting the role of physicians, attitudes regarding sexual behaviors, opinions about sexual and reproductive situations, level of comfort with sexual issues, knowledge about sexual medicine, and demographics were evaluated to determine programmatic quality and potential modifications/improvements.

Results: The majority of survey participants were white Protestant single individuals who consider themselves as somewhat liberal; half were female. The demographics of the group completing the second survey did not differ from the first group. The students’ comfort level discussing sexual topics generally improved over the interval; however, the most significant increase was in the students’ knowledge in areas such as taking a sexual history, types of birth control, sexually transmitted infections, and explaining sexual health problems. The students’ attitudes towards a variety of sexual topics varied widely, and were relatively unchanged over the interval.

Conclusion: The second sample was representative of the completers of the first survey. A longitudinal educational experience in sexuality/sexual medicine in the pre-clerkship curriculum effects medical students’ comfort level and knowledge, but not their attitudes and opinions.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

008

Female Pleasure and Orgasm: Results from a U.S. Nationally Representative Survey
Herbenick, D¹; Fu, TJ¹; Dodge, B¹; Baldwin, A¹
1: Indiana University

Objectives: To document, among a nationally representative sample of adult women in the United States, specific techniques related to female sexual pleasure and orgasm.

Methods: A cross-sectional, Internet-based, US nationally representative probability survey of 1,055 adult women. Participants reported on demographic items, specific genital touching techniques perceived as pleasurable, and genital stimulation as it relates to orgasm during intercourse.

Results: Consistent with other nationally representative surveys of American women, about two-thirds of participants reported engaging in vaginal intercourse during the previous year; a similar proportion reported partnered vagina/vulva touching in the past year. About 1 in 5 women reported that vaginal penetration alone is sufficient for their orgasm and 1 in 3 women reported that they need their clitoris to be stimulated in order to experience orgasm during intercourse. Women varied in terms of the type of pressure their preferred for vulva/vagina touching (e.g., about one-third preferred very light touch, another third preferred medium pressure, ~10% preferred firm pressure). There was also noticeable variability in terms of preferred touching techniques with most preferring up and down movements (63%) or circular movements (52%). The clitoris, the skin around the clitoris, and the labia were preferred areas of genital stimulation by a partner. The top sources from which women reported learning pleasuring techniques through self-exploration, replication of partner techniques, or reading erotica/sexy books, watching sexy movies, and watching porn.

Conclusions: There is significant variation in terms of where on their genitals women prefer to be touched, with what kind of pressure, and what motion. These data are relevant to sexual pleasure and orgasm as well as to a growing body of knowledge related to genital sensation and sexuality.

Disclosure:

Work supported by industry: yes, by For Goodness Sake, LLC.

009

An Aggressive Treatment Paradigm for the Treatment of Genito Urinary Syndrome of Menopause (GSM): A Case Series Presentation
Krychman, ML¹; Dweck, A²
1: Southern California Center for Sexual Health and Survivorship Medicine Inc.; 2: Mount Kisco Medical Group, Assistant Clinical Professor Mount Sinai School of Medicine

Introduction: GSM consists of a constellation of symptomatology that encompasses the former term vulvovaginal atrophy. This syndrome which affects the majority of menopausal woman can present with a multitude of symptoms including vaginal and vulvar burning, dysuria, itchiness, bleeding after intercourse or painful sex (dyspareunia).

Methods: A twenty-five subject case-series with diverse medical backgrounds were used from a single site for a prospective study, which implemented an aggressive treatment paradigm to treat genito urinary syndrome of menopause. Moisturizers, lubricants, minimally absorbed local estrogens, intensive dilator programs were all used in tandem to aggressively treat atrophic changes. All patients were evaluated with a detailed history, physical examination and psychosexual assessment by a sexual medicine gynecologist. Patients received either a moisturizer, lubricant or a hybrid product coupled with a detailed 1 on 1 instructional educational counseling session by a trained sexual medical assistant.

Results: 25 women were evaluated and assessed. The average age was  53 (Range  37 to 71). 21 were married, 3 single and 1 divorced.  All women presented with GSM by diagnostic criteria including an abnormal examination and confirmatory elevated PH.  The women had a diverse medical history including 20 with menopause, seven with breast cancer, five with hypothyroidism, 4 with vulvar vestibulitis and 3 with Lichen sclerosis. Fifteen women used a hybrid product including Lubrigyn Cream ® (Hybrid) or Luvena ®. All women used Lubrigyn lotion ® an external wash and mostly all used a lubricant (13 water based users; 4 silicone based products). 11 patients used a vulvar soothing cream (Neogyn ®) and 10 used a moisturizer only (Replens ® or Rephresh®). Seventeen women used a miminally absorbed local hormonal product and one woman was on an oral SERM for moderate to severe dyspareunia a symptom of VVA due to menopause.

92% or 23/25 women were able to achieve pain free intercourse within 3-4 weeks of starting this aggressive vaginal rehabilitation program

Conclusion: Aggressive vaginal rehabilitation includes multiple treatment options including hybrids, moisturizers, lubricants, dilators and vulvar cleansers, and soothing creams. Aggressive use of multiple products while tailoring to the individuals needs can help those women suffering from GSM regain sexual intercourse in a quick and efficient time frame.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

004

Hymen Protection among Female University Students from Lebanon: Temporary or Chronic Sexual Schizophrenia
El Kak, F¹; Yasmine, R¹; El Salibi, N¹; Ghandour, L¹
1: American University of Beirut, Lebanon

Objectives: Investigate how sexual practices, and values vary among females who were never concerned about hymen protection and those who still are, as compared to females who were initially concerned but then had vaginal sex.

Methods: A cross-sectional online survey was conducted among 1161 female university students (aged 18-30) from Lebanon. 

Results: 416 female students have engaged in oral and/or anal sex, of whom 61% had sexual activity with no intention of protecting their hymen, 21% only engaged in oral and/or anal sex to protect their hymen and 18% were initially concerned about hymen protection but then had vaginal sex. Females who were never concerned about hymen protection were 5 times more likely to be foreign non-Arabs compared to those who were initially concerned but then had vaginal sex (p-value=0.028). Among females who expressed concern in hymen protection, those who had later vaginal sex were 4 times more likely to report being not religious or spiritual (p-value=0.003) and 3 times more likely to be living independently compared to those who were still concerned (p-value=0.025). Adjusting for socio-demographic characteristics, females who eventually had vaginal sex were 3 times more likely to feel they engaged in sexual activities they hadn’t wished for (p-value=0.001) and ever been in a relationship where they felt things were moving too fast physically (p-value<0.0001), compared to females who were concerned about hymen protection. They were also less likely to communicate with their mother/female guardian on sexual matters (p-value=0.046) (versus never concerned). Females who expressed concern in hymen protection were twice more likely to agree that once you have had sex it is harder to say no the next time (p-value=0.011) and 3 times more likely to perceive oral sex as not as big of a deal as sexual intercourse compared to those who were never concerned (p-value=0.001). Besides, females who engaged solely in non-vaginal sex expressed more conservative attitudes related to premarital sex (p-value=0.002) and were twice more likely to feel sometimes guilty about having sexual feeling compared to those who were never concerned (p-value=0.034).

Conclusions: Within the control of the existing patriarchal societies, women, trapped in between their desire to express their sexuality and the pressure to keep family values, still managed to express their sexuality via engaging in alternative sexual practices. Further research is needed to understand the negotiation process in relation to hymen protection among females and how it shapes their sexual practices and health.

Disclosure:

Work supported by industry: yes, by Ford Foundation (industry funding only - investigator initiated and executed study).

003

A Culturally Informed Educational Program to Promote Sexual Health and Well-being Among Refugee Women
Howard, H¹; Johnson-Agbakwu, C²; Michlig, G³; Sisterna, N⁴; Nizigiyimana, J²
1: The Center for Sexual Health and Rehabilitation, USA; 2: Maricopa Integrated Health System, USA; 3: Johns Hopkins University, USA; 4: University of Arizona College of Medicine-Phoenix, USA

Objective: Refugee women may possess unique sexual health vulnerabilities as a result of experiencing cultural practices such as Female Genital Mutilation/Cutting (FGM/C) or sexual violence endemic to war and conflict. Extant sexual health educational programs do not reflect their specific educational and cultural needs. A linguistically appropriate sexual health education initiative was designed to provide information to refugee women and assess their unique needs to inform future culturally grounded interventions.

Material and Methods: A multi-phased mixed-method approach comprising a pilot session, the educational intervention, and a two-month follow-up session were conducted to assess changes in knowledge, attitudes, and sexual behaviour. Educational content was delivered in the respective languages with oral consecutive translation and visual aids. Private quantitative responses to sensitive questions were captured via an Audience Response System (ARS). Statistical analyses were performed in STATA and qualitative content analyses in Nvivo.

Results: Forty-seven adult refugee women comprising 21 Somali speakers and 26 Swahili speakers participated in a sexual health pilot session (n=21; 9 Somali, 12 Swahili), the educational intervention (n=26; 12 Somali, 14 Swahili), and the two-month follow-up session (n=19; 10 Somali, 9 Swahili). Both Somali and Swahili-speaking women requested information regarding infection prevention, low sexual desire, pain and socially undesirable reproductive outcomes. The Somali women reported primary sexual concerns of dyspareunia at first coitus (100%), forceful sex (50%), and difficulty feeling satisfied (33%), possibly as a result of FGM/C. The Swahili-speaking women reported sexual pain (73%), low desire (67%), and sex for survival (56%), against a backdrop of war-related sexual violence. At follow-up they reported positive changes, with Somali women reporting increased self-pleasuring. There was no worsening in reported sexual concerns.

Conclusion: This culturally tailored sexual health educational intervention facilitated greater women’s empowerment, health literacy, and self-efficacy around sexual health concerns. This unique approach supports community capacity-building and has the potential to be adapted for broader use to promote greater cultural competency around sexual health among providers caring for vulnerable populations with limited health literacy.

Disclosure:

Work supported by industry: yes, by Patty Brisben Foundation for Women's Sexual Health (industry funding only - investigator initiated and executed study).

002

Sexual Health and Identity-Related Interactions between Sexual Minority Women and their Healthcare Providers
Baldwin, A¹; Dodge, B²; Schick, V³; Herbenick, D²; Sanders, SA²; Fortenberry, JD⁴
1: California State University Stanislaus, USA; 2: Indiana University, USA; 3: University of Texas Health Science Center at Houston, USA; 4: Indiana University Medical School, USA

Objectives: Previous research suggests that sexual minority women (SMW) are more likely to disclose identity when seeking sexual or reproductive healthcare, and that disclosure of identity to healthcare providers is related to better outcomes and improved quality of care. Little distinction is made between identity groups (e.g. lesbian, bisexual, queer), despite the different barriers, stigma, and health outcomes that exist between them. This research examines the interactions that SMW have with their healthcare providers around sexual identity and health.

Material and Methods: Using a mixed-methods approach through an online survey tool, we gathered both qualitative and quantitative data on clinician-patient interactions around identity, sexuality and health among a sample of (N=354) lesbian, bisexual, queer and pansexual women in the United States. The qualitative and quantitative data were analyzed concurrently, and qualitative themes were quantified and explored through bivariate and regression analysis.

Results: Having to correct the assumption of heterosexuality through identity disclosure was a common negative experience among participants, who described being presumed irresponsible about pregnancy and birth control. Participants also described practitioners who fundamentally misunderstand the myriad possibilities for what “sex” might mean for sexual minority women.

Conclusion: Lesbian, bisexual, pansexual and queer women have different interpretations of their interactions with healthcare providers, different reasons for disclosing identity to providers, and different likelihoods of disclosure. The results of this study speak to ways in which improved clinician-patient interactions can enhance healthcare utilization among SMW. The findings from this study demonstrate the necessity of reprioritizing collecting information on patients’ sexual identities and histories, in order to provide them care as “whole human beings.”

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

001

Mindfulness Facilitates Sexual Arousal among Lesbian, Bisexual, and Heterosexual Women
Dickenson, JA¹; Diamond, LM¹
1: University of Utah, USA

Objectives: Mindfulness has been shown to facilitate sexual arousal among women. Yet, given the dearth of research examining this association among sexual minority women, it remains unclear whether mindfulness facilitates all sexual arousal, or strictly arousal to the preferred gender. Because mindfulness enables awareness of physiological sensations without judgment, mindfulness may facilitate awareness of physiological arousal to both preferred and non-preferred sexual stimuli (Hypothesis 1). How might mindfulness facilitate all forms of sexual arousal? Mindfulness augments parasympathetic activity, which is indicative of greater emotional and physiological regulation (“relax and digest”) and is heightened during sexual arousal. Thus, mindfulness may facilitate sexual arousal through increasing parasympathetic activity (Hypothesis 2).

Materials and Methods: Lesbian, bisexual, and heterosexual women (N=79) completed the Five Facet Mindfulness Questionnaire. Total and subscale scores were calculated. Participants engaged in a 10-minute mindfulness meditation and listened to erotic stories depicting activity with a man or a woman, while their respiratory sinus arrhythmia (RSA) was measured. Participants rated their arousal to each story (preferred and non-preferred sexual arousal) and subsequently reported their sexual arousal over 14 days (trait sexual arousal).

Results: Assessment of Hypothesis 1 indicated that the observe subscale was associated with sexual arousal, regardless of women’s sexual orientation. Individuals with a greater tendency to notice internal and external sensations showed higher levels of trait sexual arousal and preferred and non-preferred sexual arousal. Assessment of Hypothesis 2 examined whether the relation between the tendency to observe internal and external sensations and experiencing greater sexual arousal over the 14-day period was mediated by greater RSA reactivity. Coefficients of regression analyses (using SPSS 20.0) were entered into a Sobel Test online calculation tool (quantpsy.org). Results indicated that RSA during mindfulness meditation significantly mediated the relation between the observe subscale and trait sexual arousal.

Conclusions: Results suggest that for lesbian, heterosexual, and bisexual women, mindfulness, particularly the tendency to observe sensations, augments various forms of arousal through parasympathetic activity. These have important implications for basic understanding and clinical application of female sexual arousal.

Disclosure:

Work supported by industry: no.

010

A Placebo-Controlled, Randomized, Double-Blind, Three Period, Three-Way Crossover Study on the Hemodynamic and Pharmacokinetic Interactions of Bremelanotide and Ethanol
Lucas, J¹; DeRogatis, LR²; Jordan, R¹
1: Palatin Technologies, USA; 2: Maryland Center for Sexual Health, USA

Objectives: Evaluate the safety and tolerability of bremelanotide when co-administered with ethanol, and the hemodynamic and pharmacokinetic (PK) interactions in healthy test subjects.

Materials and Methods: This was a placebo-controlled, randomized, double-blind, three period, three-way crossover study. Subjects meeting the inclusion/exclusion criteria were enrolled and treated at the research facility for 7 consecutive days. Randomly assigned to one of six Treatment Paths, the subjects received single doses of 20 mg bremelanotide or placebo, administered with or without 0.6 g/kg ethanol on Study Day 1, 4, and 7. Blood samples were collected for PK evaluation. The hemodynamic effect of co-administration of bremelanotide and ethanol was examined using orthostatic vital sign checks. Vital signs, self-rated sedation scores, nursing and medical observations, and spontaneous reporting by subjects provided the basis for evaluation of adverse events (AEs). A physical examination and a resting 12-lead ECG were performed at baseline and on Study Day 7. Blood and urine were obtained for clinical safety laboratory tests.

Results: A total of 24 subjects were enrolled (12 men; 12 women), of whom all completed the study. Single doses of 20 mg intranasal bremelanotide, with exposure equivalent to approximately 1 to 2 x the subcutaneous dose currently being evaluated in Phase 3, were administered with or without 0.6 g/kg ethanol, and were found to be safe and generally well tolerated. No significant drug-related hypotensive or orthostatic hypotensive effects were noted. Treatment with bremelanotide did not result in an increased frequency of treatment-emergent AEs and no subjects discontinued from the study due to AEs or serious AEs.

Conclusions: Female sexual dysfunction (FSD) is a multifactorial condition that has anatomical, physiological, medical, psychological, and social components. Bremelanotide is a synthetic peptide analog of the naturally occurring hormone alpha-melanocyte stimulating hormone (MSH) and a melanocortin agonist that is being developed for the treatment of hypoactive sexual desire disorder (HSDD). This novel mechanism of action involves activating endogenous melanocortin hormone pathways involved in the sexual desire and arousal response. This phase 1 study demonstrates that bremelanotide and ethanol can be safely co-administered and are generally well tolerated with no reports of drug-related serious AEs.

Disclosure:

Work supported by industry: yes, by Palatin Technologies (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

011

Efficacy of Multimodal Physiotherapy Treatment Compared to Overnight Topical Lidocaine in Women with Provoked Vestibulodynia: A Bi-center Randomized Controlled Trial
Morin, M¹; Dumoulin, C²; Bergeron, SB²; Mayrand, MH²; Khalifé, S³; Waddell, G¹; Dubois, MF¹; Dubois, O¹; Study Group, PVD⁴
1: University of Sherbrooke, Canada; 2: University of Montreal, Canada; 3: McGill University, Canada; 4: Canada

Objective: To evaluate the efficacy of multimodal physiotherapy in comparison to a frequent first-line treatment, topical overnight application of lidocaine, in women with provoked vestibulodynia (PVD).

Material and Methods: We conducted a bi-centric, parallel group randomized controlled trial involving 212 women diagnosed with PVD. Women were randomly assigned to receive either weekly sessions of multimodal physiotherapy or overnight application of topical lidocaine (5% ointment) for 10 weeks. Physiotherapy treatment included education, pelvic muscle exercises with biofeedback, manual therapy and insertion techniques. The primary outcome measure was pain intensity during intercourse as assessed with the numerical rating scale (NRS 0-10) at post-treatment. Secondary outcomes included the following validated questionnaires: Female Sexual Function Index, Female Sexual Distress Scale, treatment satisfaction (0-10) and Patient’s Global Impression of Change. Outcome assessors, investigators and the person in charge of data analysis were blinded to group assignation. Analysis was conducted by intention to treat, and treatment effects were calculated with repeated measure analysis of variance.

Results: Two hundred one participants (95%) completed the study. Both physiotherapy and lidocaine showed significant changes from baseline to post-treatment on all outcomes (all p<0.01). However, physiotherapy treatment was found more efficacious than lidocaine for reducing pain during intercourse. Mean (±SD) baseline and post-treatment pain intensity for the physiotherapy group were 7.3±1.5 and 2.9±2.1, versus 7.3±1.5 and 4.5±2.6 respectively for the lidocaine group (changes from baseline between the two groups 1.5 CI95% 0.9-2.1, p<0.001). Physiotherapy was also found more efficacious in reducing sexual distress as well as improving sexual function (p<0.001). Women in the physiotherapy treatment group also reported higher satisfaction with treatment (8.8/10 (SD1.4)) compared to lidocaine (5.5/10 (SD3.2); p<0.001)). Overall, 77% of women in the physiotherapy group reported being very much or much improved compared to 38% in the lidocaine group (p<0.001).

Conclusion: Findings of this study provide strong evidence that multimodal physiotherapy is effective for reducing pain and sexual distress as well as improving sexual function in women with PVD. Physiotherapy proved to be more effective than a frequent first-line treatment - overnight lidocaine topical application.

Disclosure:

Work supported by industry: no.

012

Potential Sexual Changes Resulting from LEEP
Rollston, R¹; Dell, A²; Komisaruk, BR³; Goldstein, SW⁴; Goldstein, I⁵
1: ETSU Quillen College of Medicine, USA; 2: UK; 3: Rutgers, USA; 4: San Diego Sexual Medicine, USA; 5: Alvarado Hospital, USA

Objectives: Komisaruk has provided evidence that the cervix is uniquely innervated by three separate neural pathways including the pelvic, hypogastric and vagus nerves. Cervical stimulation can induce orgasm. As described by some women, their cervical/myometrial orgasms are intense, sustained orgasm associated with deep myometrial contractions, that are exhausting and fulfilling and that are separate and distinct from more frequently described clitoral or anterior vaginal wall, peri-urethral stimulation orgasms. Women who have a hysterectomy lose their ability to have cervical/myometrial orgasm. Loop electrosurgical excision procedure (LEEP) was developed to treat women with biopsy-demonstrated abnormal cervical cells and to avoid hysterectomy. LEEP coagulates abnormal cervical tissue and surrounding blood vessels to prevent bleeding.

Materials and Methods: Motivated by a woman who was diagnosed with mild cevical dyskaryosis and underwent a LEEP and subsequently lost her orgasmic function, we performed a literature review using key words “orgasm”, “sexual function”, “LEEP procedure” etc.. It was hypothesized that LEEP may negatively impact sexual function in a subgroup of women by disrupting neural pathways that innervate the cervix.

Results: Our patient reported “feeling something wrong” post LEEP. Post-op, an intimate encounter with her partner resulted in decreased pleasure and inability to reach orgasm, although a mild contraction in the cervix was felt. Upon self-exploration the patient claimed her labia felt different, “unsensual,” and thereafter was unable to experience a strong climax or sexual fantasies, and only a warm feeling in her clitoris. Since the LEEP, she reports also having vaginal dryness and claims “mental numbness.” Inna reported on 89 premenopausal women with cervical dysplasia who had undergone LEEP at least 3 months previously, and were interviewed once on post-LEEP follow-up visits with a questionnaire on pre- and post-procedural sexual function. Inna found that the changes in the frequency of sexual intercourse, dysmenorrhea, and dyspareunia after LEEP were not statistically significant but the decreases in overall satisfaction, vaginal elasticity, and orgasmic satisfaction were statistically significant.

Conclusion: During LEEP, the triple cervix innervation is at risk for injury and may result in reduced sexual satisfaction and orgasm dysfunction.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

013

Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy
Labrie, F.¹; DeRogatis, L²; Archer, DF³; Martel, C¹
1: EndoCeutics Inc., Canada; 2: Maryland Center for Sexual Health, USA; 3: CONRAD Clinical Research Center, USA

Objective: Previous data have shown that intravaginal dehydroepiandrosterone (DHEA, prasterone) improved all the domains of sexual function, an effect most likely related to the local formation of androgens from DHEA. The objective was to confirm in a placebo-controlled, prospective, double-blind and randomized study the benefits of daily intravaginal DHEA for 12 weeks on sexual function using the Female Sexual Function Index (FSFI) questionnaire.

Material, Patients and Methods: Placebo was administered daily to 157 women while 325 women received 0.50% (6.5 mg) DHEA daily for 12 weeks. All women were postmenopausal meeting the criteria of vulvovaginal atrophy (VVA), namely moderate to severe dyspareunia as their most bothersome symptom of VVA in addition to having ≤5% of vaginal superficial cells and vaginal pH>5.0. The FSFI questionnaire was filled at baseline (screening and Day 1), 6 weeks and 12 weeks. Comparison between DHEA and placebo of the changes from baseline to 12 weeks was made using the ANCOVA test, with treatment group as the main factor and baseline value as the covariate. The six domains and total score of the FSFI questionnaire were evaluated.

Results: The FSFI domain desire increased over placebo by 0.24 unit (+49.0%, p=0.0105), arousal by 0.42 unit (+56.8%, p=0.0022), lubrication by 0.57 unit (+36.1%, p=0.0005), orgasm by 0.32 unit (+33.0%, p=0.047), satisfaction by 0.44 unit (+48.3%, p=0.0012) and pain at sexual activity by 0.62 unit (+39.2%, p=0.001). The total FSFI score, on the other hand, has shown a superiority of 2.59 units in the DHEA group compared to placebo or a 41.3% greater change than placebo (p=0.0006 over placebo).

Conclusion: The present data show that all the six domains of the FSFI are improved over placebo (by 33.0% to 56.8% and from p=0.047 to 0.0005), thus confirming the previously observed benefits of intravaginal DHEA on female sexual dysfunction by an action exerted exclusively at the level of the vagina, in the absence of biologically significant changes of serum steroid levels.

Disclosure:

Work supported by industry: yes, by EndoCeutics Inc. (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

014

A Phase 2 Program on Female Sexual Arousal Disorder and Hypoactive Sexual Desire Disorder: Patient Characteristics and Implications for Diagnosis and Treatment of Female Sexual Dysfunction
Althof, S¹; Kingsberg, S²; Symons, J³; Portman, D ³
1: Center for Marital and Sexual Health of South Florida; 2: University Hospitals Case Medical Center; 3: Sermonix Pharmaceuticals

Objectives: DSM-5 has combined the previously separate female sexual dysfunctions (FSD) of arousal and desire disorders into a single diagnosis, Female Sexual Interest/Arousal Disorder (FSAID). The implications of this change in terms of patient characteristics and on clinical investigations are unknown. A series of four randomized, double-blind, placebo-controlled trials were conducted to investigate the effect of lasofoxifene, an estrogen agonist/antagonist, on postmenopausal female sexual arousal disorder (FSAD) and hypoactive sexual desire disorder (HSDD) and may provide insight into the differences between these populations and the potential impact of the new DSM-5 diagnostic criteria on clinical trial design.

Materials and Methods: Postmenopausal women at least 44 years old were diagnosed based on these Sexual Function Questionnaire (SFQ) scores: For FSAD studies, a score of < 18 on the arousal subscale, and for HSDD studies, a score of <23 on the desire subscale. 681 women were enrolled in the FSAD studies, and 803 enrolled in the HSDD studies. All studies required a score of >15 on Female Sexual Distress Scale (FSDS), baseline number of satisfying sexual events (SSEs) and a structured interview conducted by a trained sexual medicine professional. Certain general health criteria also needed to be met from an inclusion or exclusion perspective.

Results: Women were 54-55 years of age on average. Regardless of their primary diagnosis, all women had desire and arousal scores that would indicate a dysfunction associated with those states. Likewise, the mean number of SSEs at baseline was no different in all of the groups in the studies, i.e., there was no distinguishable effect on the number of SSEs at baseline for either FSAD or HSDD groups. Finally, the level of distress associated with either FSAD or HSDD was not distinguishable between studies or groups at baseline.

Conclusion: There were significant areas of overlap in symptoms of arousal and desire in this phase 2 program. A structured interview was able to differentiate between FSAD and HSDD. The impact DSM-5 and a merger of arousal and desire disorders have on clinical trial enrolment and design is an important area for future research.

Disclosure:

Work supported by industry: yes, by Sermonix Pharmaceuticals (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

015

Evaluation of Clinical Meaningfulness in the Flibanserin HSDD Clinical Development Program
Simon, J¹; Brown, L²; Yuan, J²; Spigelman, S³
1: George Washington University and Women's Health and Research Consultants, USA; 2: Sprout Pharmaceuticals, Inc., USA; 3: Valeant Pharmaceuticals, Inc., USA

Objective: To evaluate the Patient Global Impression of Improvement (PGI-I) to measure the clinical relevance of the magnitude of effect seen in the key efficacy endpoints in the Phase 3 pivotal flibanserin trials.

Methods: Patient reported outcomes (PROs) were used to capture the key efficacy endpoints in flibanserin’s pivotal trials. Sexually Satisfying Events (SSEs) were captured using an electronic diary, sexual desire was measured using two methods, the desire domain of the Female Sexual Function Index (FSFI-D) and an electronic eDiary Desire and sexual distress was measured using the Female Sexual Distress Scale Revised (FSDS-R), item 13. The PGI-I was used as a clinical anchor to define responders for each of these endpoints. A responder was defined as a patient with a change from baseline in the endpoint value that was greater than the response threshold defined by the difference between "minimally improved" (score of 3) and "no change" (score of 4) on the PGI-I. Similar methodology was used to define responders for FSFI-D and FSDS-R13.

Results: The number of subjects who self-reported as responders based on a PGI-I score of 3 or better on SSE, FSFI-D and FSDS-R13, at Week 24 (FAS, LOCF) between flibanserin and placebo ranged from 9.7% (P< 0.01) to 14.6% (P=0.0004). The mean change from baseline at Week 24 in SSE for the responder group ranged from 4.3 to 5.8 SSE per month, compared to 1.9 to 2.5 SSE in the FAS, scores on the FSFI-D score ranged from 1.9 to 2.0 in responders compared to 0.9 to 1.0 in the FAS and on the FSDS-R13 responder scores ranged from -1.7 to -1.8 compared to -0.7 to -1.0 in the FAS.

Conclusion: In flibanserin’s pivotal trials, the PGI-I was used as an anchoring method to translate the magnitude of effect seen on validated and reliable PROs into a clinical meaningful change for the patient. A comparison of flibanserin’s FAS to the responder group showed that responders reported mean changes in key symptoms that, at times, was double the effect in the overall flibanserin treatment group, with an increase of more than 5 SSEs per month, an approximate two-point increase on the 4.8-point desire scale and an approximate 1.8-point improvement on the 5-point distress scale over baseline.

Disclosure:

Work supported by industry: yes, by Sprout Pharmaceuticals (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

016

Vulvoscopic Findings, Patient Reported Outcome (PRO) Measures, and Hormonal Blood Test Values in Menopausal Women with Female Sexual Dysfunction Pre- and Post-Hormonal Treatment: A Retrospective Single Center Study
da Silva, S¹; Espenschied, C²; Gagnon, C²; Minton, J³; Goldstein, I⁴
1: UCSD, USA; 2: San Diego Sexual Medicine, USA; 3: San Diego Sexual Medicine, USA; 4: Alvarado Hospital, USA

Objectives: Menopausal women frequently experience symptoms and signs associated with reduced sex steroid hormones. Estradiol deficiency related symptoms of GSM include dryness, burning, thinning, itching, urinary frequency and dyspareunia. Testosterone deficiency related symptoms include diminished sense of well-being, reduced muscle and bone mass, provoked vestibulodynia, and decreased sexual desire, arousability, and orgasmic pleasure. The hypothesisis is that with both high patient adherence and close health care provider monitoring, hormonal management will lead to subjective and objective improvements in signs and symptoms.

Materials and Methods: The aim of this study was to evaluate clinical benefit of hormonal replacement strategies for management of sexual dysfunction and GSM utilizing pre- and post-treatment: blood test monitoring; FSFI scores; and vulvoscopy findings. Charts from August 1, 2007 through December 1, 2015 were reviewed. Five bioidentical hormonal replacement efforts are designed to keep serum estradiol levels 35 - 50 pg/ml, serum progesterone levels at 1.0 ng/ml and calculated free testosterone levels at 0.8 ng/dl including daily topical vestibular and vaginal estradiol and testosterone applications. Subjects included were peri-menopausal or post-menopausal at their initial visit, naturally or surgically, and have both an initial and at least one follow-up vulvoscopy. Exclusions included cosmetic vulvar or vestibular surgery.

Results: 110 menopausal women (mean age 62 +/- 13 years) with sexual health complaints met study criteria. Mean follow-up was 2.6 +/- 1.3 years. Pre-treatment vulvoscopic findings of labia minora resorption, urethral meatus telescoping, clitoral atrophy, vestibular erythema tenderness and pallor, minimally robust peri-urethral tissue, minimal vaginal rugae, with thin, pale vaginal mucosa and abnormal vaginal pH were noted in 100%. Serum sex steroid values returned to ideal values in 81%. FSFI total scores increased more than 5 points in 72%. Post-treatment vulvoscopic changes revealed pink moist pain-free vestibular tissue in 63%.

Conclusion: Managing menopause with patient adherence and close monitoring, hormonal menopausal management has lead to subjective and objective improvement of female sexual function.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

017

Meta-Analysis of Orgasmic and Overall Sexual Function Post Mid-Urethral Sling Surgery
Szell, N¹; Komisaruk, B²; Qu, H³; Shaw, M¹; Goldstein, S⁴; Goldstein, I⁴
1: St. John Providence Health System, USA; 2: Rutgers University, USA; 3: Oakland University, USA; 4: San Diego Sexual Medicine, USA

Objectives: More than 200,000 mid-urethral slings are placed yearly for stress urinary incontinence. About 14-20% of women experience worsening sexual function after sling placement and about 30% report worsening orgasm frequency/intensity, with statistically significant lowering of pre-op vs. post-op orgasm FSFI and PISQ scores. We postulate sling placement injures neural pathways regulating “female prostate” peri-urethral tissue lying adjacent to anterior vaginal wall. Meta-analysis for overall sexual function and orgasm was performed using FSFI and PISQ for transvaginal tape (TVT) and transobturator tape (TOT).

Materials and Methods: Effect sizes of pre-op and post-op questionnaire scores for overall sexual function and orgasm from the studies were calculated. Random-effects models were selected for Meta analyses. Statistical analysis involved determination of the ratio of total heterogeneity among various studies to total variability. The difference of overall sexual and orgasm functions were calculated by subtracting post-mid-urethral sling scores from pre-sling scores. Forest plots of effect sizes for overall sexual function were performed.

Results: Statistical analysis for the difference in orgasm showed the mean post-op score was significantly higher than mean pre-op score. For TVT alone, mean total sexual function and orgasm post-op scores were significantly higher than pre-op scores. For TOT alone, the mean total post-op score was significantly higher than pre-op, however the mean orgasm post-op score was not significantly higher than pre-op, mainly due to large variation in TOT data. Although the mean total and orgasm effect sizes were similar for TOT and TVT, the TOT effect sizes have much larger variations than TVT.

Conclusions: We believe the data support that a subgroup of women who derive primary orgasmic function from vaginally-elicited orgasms, through penetration or stimulation of the peri-urethral female prostate region, may lose this response following sling placement. The dissection for and placement of the mid-urethral sling clearly can compromise neural integrity of anterior vaginal wall, peri-urethral female prostate tissue.

Disclosure:

Work supported by industry: no.

019

Sex Steroid Hormones Regulation of Relaxation and Contractile Mechanisms in Clitoris: An Experimental Model in the Rat
Filippi, S¹; Cellai, I¹; Corno, C¹; Corcetto, F¹; Comeglio, P¹; Maseroli, E¹; Rastrelli, G¹; Maggi, M¹; Vignozzi, L¹
1: University of Florence, Italy

Objectives: Although the crucial role of tumescence of clitoris in sexual response has been established, the underlying molecular mechanisms are still poorly understood. Preclinical studies suggest that nitricoxide (NO), through the second messenger cGMP, is the main vasodilator neurotransmitter modulating the clitoral flow vessels. Aim of the present study is to investigate the effects of sexual steroid hormones on pro-erectile/relaxant (NO/cGMP mediated) and anti-erectile/contractile (RhoA/ROCK mediated) mechanism in clitoris using a validated animal model.

Material and Methods: Female Sprague Dawley rats were ovariectomized (OVX). Subgoups of OVX were treated with either estradiol (E2; 10μg/ Kg/ day), progesterone (P; 10mg /kg/ day), testosterone (T; 30mg/ kg/ week) or T+ letrozole (T; 30mg/ kg/ week; letrozole: 2,5 mg/kg/ day) for six weeks. The experimental groups were compared with a control group of intact rats.

Results: By using real-time PCR we observed that testosterone treatment upregulates the expression of NO-mediated pathway genes (eNOS, nNOS, sGC, PDE5, PKG1). Conversely, estrogen replacement regulates the expression of calcium- sensitizing RhoA/ROCK pathway. Accordingly, we also performed in vitro contractility studing, on phenylephrine pre-contracted clitoris strips. OVX was associated with a reduced responsiveness to Y-27632, a ROCK inhibitor, which was fully restored by E2 supplementation. Finally, to further examine the effect of 17β-estradiol on the RhoA/ROCK pathway, we isolated smooth muscle cells for rat clitoris and evaluated their migration capacity.

Conclusions: Collectively, our data demonstrate that T improves vascular smooth muscle cells relaxation through the NO/cGMP pathway, and that testosterone and estradiol are both necessary to mantain a functional contractile and relaxant machinery in clitoris.

Disclosure:

Work supported by industry: no.

020

Mechanism of Action and Preliminary Clinical Experience with Zolpidem, a Non-Benzodiazepine Indirect GABA A Receptor Agonist, for Symptomatic Treatment of Persistent Genital Arousal Disorder (PGAD)
King, SA¹; Goldstein, I¹; Pfaus, J²
1: Alvarado Hospital, USA; 2: Concordia University, Canada

Objectives: Persistent Genital Arousal Disorder (PGAD) is characterized by persistent or recurrent, unwanted or intrusive, bothersome or distressing feelings of genital arousal or being on the verge of orgasm, genital dysesthesia, not associated with concomitant sexual interest, thoughts or fantasies. With no FDA-approved treatments, strategies to manage PGAD include: elimination of excess sensory excitation from various peripheral genital (S2, S3, S4) or central nervous system pathologies centrally misdirected to the hypothalamus and misinterpreted as genital arousal/orgasm; inhibition of central relay information to the hypothalamus.

Materials and Methods: A woman with severe unrelenting PGAD was serendipitously administered zolpidem for sleep and noted temporary but dramatic resolution of PGAD symptoms. The mechanism of action of zolpidem was reviewed and other patients with PGAD were clinically offered zolpidem for symptom reduction.

Results: Incertohypothalamic dopamine release in the medial pre-optic area is a major controller of sympathetic outflow, activated in sexual circumstances to dilate peripheral blood vessels for genital arousal and facilitate sexual desire. Zolpidem, an FDA-approved fast-acting non-benzodiazepine indirect GABA A receptor agonist, potentiates GABA release modifying the benzodiazepine binding site. Brain dopamine neurons are inhibited by GABA neurons, with small axons contacting dopamine cell bodies shutting down dopamine transmission, keeping it in check when activated. Benzodiazepines are used clinically to diminish dopamine release by activating GABA release in adjacent neurons, although the effect takes longer to produce and has more severe side effects than zolpidem. Dopamine in various regions of the hypothalamus acts to keep one awake by opposing serotonin-associated sleep induction. Zolpidem acts to knock out dopamine and release serotonin from inhibition, resulting in sleep. If PGAD is in part due to a hypofunctioning GABA system in the hypothalamus allowing dopamine to run uninhibited, then zolpidem is hypothesized to normalize GABA release, reduce dopamine and allow serotonin increase reducing PGAD symptoms. We now have preliminary successful experience with low doses of zolpidem ( 1 – 2.5 mg q 6 hours) in more than 10 PGAD patients.

Conclusions: Pharmacologic management of PGAD may be achieved by agents that lower dopamine and raise serotonin such as zolpidem, however more research is needed.

Disclosure:

Work supported by industry: no.

022

Effect of Fractional CO2 Laser on Vulvo-Vaginal Atrophy in Post-Menopausal Women with Dyspareunia Based on FSFI Data
Cohen, S¹; Sophocles, M²
1: Lenox Hill Hospital, USA; 2: Women’s Healthcare of Princeton, USA

Aim: To evaluate, with validated instruments, sexual function in post-menopausal women with dyspareunia secondary to vulvo-vaginal atrophy (VVA) who received 3 treatment cycles of fractional CO2 laser on vaginal tissue.

Design: Retrospective chart review.

Patients and Methods: 18 otherwise healthy post-menopausal women presenting with dyspareunia secondary to VVA, average age 59 (range: 46-71 years), were evaluated using the Female Sexual Function Index (FSFI) questionnaire before and after laser therapy. All 18 women underwent treatment in an outpatient clinic with no anesthesia. Each patient received 3 laser treatments spaced 6 weeks apart. Length of follow-up was 18 weeks - 10 months.

Results: Overall, 17/18 women (94%) who received the laser treatment reported experiencing a meaningful treatment benefit. Mean pre-laser FSFI scores were 14.41 +/- (2.7/27.9) and mean post-laser FSFI scores improved to 23.7 +/- (4.1/34.8). More specifically, mean pre-laser lubrication and orgasm scores were 1.98 +/- (0/4.8) and 2.84 +/- (0/6) and mean post-laser lubrication and orgasm scores improved to 4.56 +/- (0.9/6) and 4.11 +/- (0/6). Mean pre-laser satisfaction and pain scores were 3.13 +/- (0/6) and 1.46 +/- (0/5.6) and mean post-laser satisfaction and pain scores improved to 3.88 +/- (0/6) and 3.77 +/- (0/6).  The most common side effects reported were mild vaginal irritation and spotting for 24 hours, both of which resolved on their own without intervention.

Conclusions: The most common therapy used to manage VVA currently is estrogen. Because the US Food and Drug Administration (FDA) released a “black box” warning on post-menopausal hormone use in women, providers treating these women have been waiting for a non-hormonal treatment to be approved. Fractional CO2 lasers supply energy to the vaginal wall to superficially ablate the epithelial component of atrophic mucosa, ultimately triggering the synthesis of new collagen formation. We found the use of fractional CO2 laser treatment to treat VVA in post-menopausal women resulted in clinically meaningful benefits with a low side effect profile.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

023

Pelvic Nerve Injury Leads to Increased Rho-Kinase Mediated Adrenergic Vasoconstriction of the Distal Vagina
Hannan, JL¹; Powers, SA¹; Butner, A¹; Wang, VM²; Tepper, J³; Liu, X³; Bivalacqua, TJ³
1: East Carolina University , USA; 2: Dept. Urology, Johns Hopkins Medical Institutes, Baltimore, MD, USA; 3: Dept. Urology, Johns Hopkins Medical Institutes, Baltimore, MD

Objectives: Female sexual responses rely on innervations from the pelvic plexus which may become damaged during radical hysterectomy. We demonstrated that bilateral pelvic nerve injury (BPNI) leads to increased vaginal adrenergic contractions and impaired vaginal blood flow in rats. This study examined the role of Rho-kinase (ROCK) in the elevated vaginal contractions after BPNI.

Materials and Methods: Female Sprague-Dawley rats (12 wks) were divided into sham or BPNI in which nerves from the pelvic plexus were bilaterally crushed. Animals were examined 3, 7, 14, 30 days following BPNI. Distal vaginal strips were contracted to the adrenergic agonist, norepinephrine (NE) or by electrical field stimulation (EFS) in the presence/absence of ROCK inhibitor Y-27632. Non-adrenergic, non-cholinergic (NANC) relaxation of the vaginal tissue was also assessed by EFS. ROCK1, ROCK2, RhoA, and α-smooth muscle actin (ASMA) protein and gene expression were assessed by Western blot and qPCR. Vaginal tissue was formalin fixed, paraffin embedded and sections were stained with Masson’s trichrome to assess smooth muscle and collagen. Additional sections were stained for tyrosine hydroxylase (TH) to assess sympathetic innervation of vaginal smooth muscle.

Results: An increase in vaginal contraction to NE and EFS was evident 3, 7, 14 days following BPNI (p<0.05). These increases in adrenergic mediated contractions following BPNI were significantly lower following ROCK inhibition by Y-27632 (p<0.05). NANC relaxation in the vagina was impaired 7 and 14 days post-BPNI (p<0.05). Gene expression of ROCK1, ROCK2 was increased 14 days after BPNI and its activator RhoA was also increased at 3 and 14 days compared to sham (p<0.05). Similarly, protein expression of ROCK1, ROCK2 and activated RhoA were elevated 3, 14 days after BPNI (p<0.05). A significant decrease in ASMA protein was evident at 7, 14 days after BPNI. Increased collagen and TH positive nerve terminals in the vaginal wall and a decrease in vaginal epithelium were evident14 days after BPNI.

Conclusions: Pelvic nerve injury leads to increased adrenergic, rho-kinase mediated tone, and structural changes to the vagina. These findings parallel the phenotype in the penis after cavernous nerve injury and provide us with a possible therapeutic target for neuropraxia-induced vaginal dysfunction.

Disclosure:

Work supported by industry: no.

024

The Impact of Fiera™, a Women’s Sexual Health Consumer Product, on Premenopausal Genital Engorgement as Measured by Thermography: A Proof of Concept Study
Goldstein, S¹; Goldstein, I¹; Millheiser, L²
1: San Diego Sexual Medicine, USA; 2: Nuelle, Inc., USA

Objective: The primary aim of this study was to determine the degree of engorgement, as measured by temperature change in the external genitalia, produced by Fiera™, a women’s sexual health consumer product, utilizing suction and vibration technology to enhance genital blood flow. The secondary aims were to determine the time of onset of self-reported sexual arousal during use of the product as well as development of sexual desire.

Materials and Methods: A single-site, prospective, non-blinded study of Fiera™ was conducted in 14 sexually-active, premenopausal women (mean age: 37.1 + 9.0 years). Cohort-eligible women must have had a Female Sexual Function Index (FSFI) total score > 26.5, and have been sexually active in the 30 days prior to enrollment. Each subject underwent a single-visit procedure that included the establishment of baseline temperature, use of Fiera™ over the clitoris, and post-product skin temperature assessment. Temperature at the clitoris, labia and vestibule was measured using Forward Looking InfraRed Thermography. Participants self-recorded time to onset of sexual arousal during use of Fiera™. At the end of the procedure development of sexual desire was assessed using a Likert scale.

Results: A two-sided paired t-test was used to assess the statistical significance of the temperature increase from baseline to post-product use. The temperature increases for the clitoris and vestibule were statistically significant at all time points up to 10 minutes following removal of Fiera™. Temperature increase for the labia was only significant up to 8 minutes. The most significant temperature increase was observed at 0 minutes for all sites (p < 0.0001). All of the participants developed sexual arousal during use of Fiera™ with the average time to onset being 5.2 + 4.2 minutes. Forty-three percent of participants (n=6) strongly agreed that they “felt in the mood for sex” after use of the product, 50% (n=7) agreed, and 7% (n=2) somewhat agreed. None of the participants disagreed with the statement. No adverse events were reported during the study period.

Conclusion: Fiera™ produced statistically significant increases in vulvar temperatures, which is a marker of genital blood flow and engorgement. A notable finding that warrants further investigation is the congruence between genital arousal and development of sexual desire as a result of Fiera™ use in this population.

Disclosure:

Work supported by industry: yes, by Nuelle, Inc. (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

025

A Brief Intervention to Increase Heart Rate Variability Increases Physiological Sexual Arousal in Sexually Functional Women: Results from a Pilot Study
Stanton, A¹; Del Rey, G¹; Nichols, L¹; Meston, C¹
1: The University of Texas at Austin, USA

Introduction: Heart rate variability (HRV) has recently been associated with female sexual function. Specifically, below average HRV was identified as a significant risk factor for sexual arousal dysfunction and overall sexual dysfunction in women (Stanton, Lorenz, Pulverman, & Meston, 2015). Building upon this newly established relationship, the present study examined the effect of a brief intervention to increase HRV on physiological sexual arousal in sexually functional, college-aged women. Vaginal pulse amplitude (VPA), an index of genital sexual arousal, was assessed in 32 sexually functional women, aged 18-27, before and after a short session of autogenic training, which has been shown to significantly increase HRV (Miu, Heilman, & Miclea, 2009). Autogenic training is a relaxation technique that restores the balance between the activity of the sympathetic and the parasympathetic branches of the autonomic nervous system through suggestive phrases directed at certain parts of the body. We hypothesized that brief autogenic training would lead to a significant increase in both HRV and VPA.

Objectives: To assess the effect of brief autogenic training on both HRV and VPA in sexually healthy women

Materials and Methods: Vaginal photoplethysmography and electrocardiography were used to assess VPA and HRV, respectively. Both VPA and ECG were recorded using Biopac MP150 (Biopac Systems, CA, USA) at a sample rate of 200 samples/sec.

Results: Significant increases in mean HRV, post-autogenic training, were observed (p <.001). Significant increases in mean VPA, post-autogenic training, were also observed (p = .04).

Conclusions: HRV may be an important mechanism of physiological sexual arousal in women. More importantly, if replicated in women with sexual arousal dysfunction, this finding could have important implications for developing new, cost-effective treatments for sexual arousal concerns.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

026

Sexual Concerns for Women with Gynecologic Cancer: Does Age Make a Difference?
Abbott-Anderson, K¹; Kwekkeboom, KL²
1: Minnesota State University, USA; 2: University of Wisconsin, Madison

Objectives: The purpose of this study was to: 1) identify physical, psychological and relational sexual concerns reported by women with gynecological (GYN) cancer and 2) compare the number and intensity of physical, psychological and relational sexual concerns between younger and older women.

Material and Methods: N=260 GYN cancer survivors (mean age 59.8 [SD: 11.22]) diagnosed three months to five years prior to the study were recruited from a comprehensive cancer center. Participants completed the Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC), a new instrument containing 34 physical, psychological and relational sexual concerns (Likert Scale: 0 [no concern]-5 [extremely concerning]) during a clinic visit. Sexual concern item wording began with the phrase “Since my cancer treatment began”.

Results: Eighty-two percent of participants with ages spanning the full sample range reported sexual concerns. Of the possible 34 sexual concerns, 15 had a mean score >1.00, meaning that participants had at least a slight level of concern for those items. Top concerns (with ≥50% of the sample reporting at least a slight concern) included “I’m not as sexually active” and “I have less interest in sex”. The most intense sexual concerns included “I’m not as sexually active’ (M=2.84 [SD=1.34]) and “I have vaginal dryness during sex” (M=2.72 [SD=1.47]). T-tests comparing younger and older women on number and intensity of physical, psychological, and relational concerns revealed statistically significant group differences for all comparisons. In each case, younger women reported more and greater intensity of sexual concerns compared to older women.

Conclusions: Women of all ages in the sample endorsed sexual concerns. Younger women endorsed higher numbers and intensity of sexual concerns compared to older women. This finding is consistent with the literature and suggests that younger women may be at particular risk for sexual concerns following GYN cancer diagnosis and treatment. Though younger women reported more sexual concerns, it is important to note that older women also endorsed sexual concerns following GYN cancer, and therefore, older women should not be excluded from future studies as has occurred in some studies. Interventions to address sexual concerns and alleviate distress related to sexual concerns may be most impactful, however, for younger GYN cancer survivors.

Disclosure:

Work supported by industry: no.

021

Correlation of Physiologic Markers of Vulvovaginal Atrophy and Symptom Severity in Postmenopausal Women with Genitourinary Syndrome of Menopause
Krychman, M¹; Symons, J ²; Portman, D²
1: Southern California Center for Sexual Health and Survivorship Medicine, USA; 2: Sermonix Pharmaceuticals, USA

Objectives: Lasofoxifene, a selective estrogen receptor modulator has demonstrated significant improvement in self-reported most bothersome moderate to severe symptoms (MBS) of postmenopausal vulvovaginal atrophy (VVA) in two large, randomized, placebo controlled clinical trials. In addition to the assessment of MBS, physiological markers of VVA were also obtained, including vaginal pH, superficial and parabasal cells, and all demonstrated a significant response to lasofoxifene treatment by 12 weeks. The objective of the present analysis was to investigate a possible association between symptom severity and these various physiological measures.

Methods: Two clinical trials were conducted and randomized 444 and 445 subjects, respectively. All subjects provided informed consent and met all inclusion criteria. Prior to randomized treatment to either 0.25 mg or 0.5 mg of lasofoxifene or placebo each women identified a MBS chosen from the following: vaginal dryness, vulvar and/or vaginal itching, dysuria or dyspareunia. Vaginal pH, superficial and parabasal cells were also measured at baseline and week 12. Analyses were performed to determine whether moderate symptoms differed from severe symptom severity for each physiological measure. Parabasal cells and pH were assessed using the Wilcoxon test, while superficial cells were analyzed using chi-squared test.

Results: Generally few consistent significant differences between moderate and severe symptoms were noted for the three physiological measures. The exception to this finding was for dyspareunia, in which both studies had significant differences between moderate and severe symptom severity and percentage of parabasal cells. Subjects with moderate dyspareunia had parabasal cells percentages of 41.57 and 46.22 in the two studies, while severe subjects had an average of 56.22 and 57.14. The differences were statistically significant (p<0.01).

Conclusions: Severity of VVA symptoms in these studies could not be predicted based on physiologic assessments except for the difference for severe dyspareunia and percentage of parabasal cells. Whether parabasal cell count can be used as a biomarker for patients at risk for severe dyspareunia requires further study.

Disclosure:

Work supported by industry: yes, by Sermonix Pharmaceuticals (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

027

VIVEVE I: VIveve Treatment of the Vaginal Introitus to Evaluate Effectiveness: An Interim Analysis
Krychman, ML¹; Wilkerson, D²
1: Southern California Center for Sexual Health and Survivorship Medicine Inc.; 2: Senior Director, Clinical Affairs, Viveve, Inc.

Introduction: Vaginal tissue laxity has often been overlooked as a contributing etiological factor to female sexual dysfunction. Vaginal looseness can lead to diminished physical sensation during intercourse. This reduction of sensation is often coupled with a reduction in sexual satisfaction, which can also impact a woman’s relationship with her sexual partner. The Viveve System is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a nonablative and minimally-invasive approach to creating heat deep within the layers of vaginal soft tissue, while keeping the surface cool. The Viveve procedure consists of a single, 30-minute, office-based, treatment of the vaginal introitus to improve sexual function. Interim prospective, controlled, randomized data is promising and presented here.

Methods: A prospective, longitudinal, randomized, blinded, controlled, multi-center clinical study is ongoing. This study is the first of its kind ever done for the medical condition of vaginal laxity. Over 150 subjects were randomized in a 2:1 ratio to either the active treatment group (90 J/cm²) or sham group (1 J/cm²). Subjects will be followed up at 72 hrs, 10 days, and 1, 2, 3, and 6 months post-treatment. Clinical scales for assessment include Female Sexual Function Index (FSFI), Vaginal Introitus Laxity Inventory (VALI), Female Sexual Distress Scale-Revised (FSDS-R), and the Viveve System Questionnaire (VSQ).

Results: An unblinded interim analysis was performed in July 2015 on all enrolled subjects (who did not have a major protocol deviation and in whom 3 month data was available) to reassess the sample size estimate and examine the safety profile in each treatment group. Early results suggest a positive effect of the Viveve system at 3 months, compared to placebo. Additionally, the procedure was well tolerated, with no serious adverse events reported and no topical anesthetics used or required.

Conclusion: In-office, targeted radiotherapy with cooling treatments show excellent promise for safe and effective treatment of vaginal laxity to improve sexual function.  To date over 1,000 women have been treated worldwide and no serious adverse events have been reported. Final analysis is forthcoming in the middle of 2016.

Disclosure:

Work supported by industry: yes, by Viveve, Inc.. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

018

Rejoice Trial: Evaluation of an Applicator-free Vaginal Estradiol Softgel Capsule for the Treatment of Postmenopausal Dyspareunia Associated with Vulvar and Vaginal Atrophy (VVA)
Constantine, G¹; Bernick, B²; Kushner, H³; Mirkin, S²
1: EndoRheum Consultants LLC, Malvern, PA; 2: TherapeuticsMD Inc, Boca Raton, FL; 3: Biomedical computer Research Institute, Philadelphia, PA

Objective: TX-004HR is an investigational applicator-free vaginal softgel capsule containing 17β-Estradiol (E2) designed to provide adequate efficacy, low systemic absorption, easy insertion, complete dissolution to minimize vaginal discharge after administration. The Rejoice trial, a phase 3 clinical study, evaluated the efficacy and safety of TX-004HR in postmenopausal women with moderate-severe symptoms of vulvar and vaginal atrophy (VVA). For treatment of VVA symptoms, FDA guidance recommends demonstrating statistically significant improvement from baseline in: superficial vaginal cells, parabasal vaginal cells, vaginal pH, and the moderate to severe VVA symptom identified by the patient as the most bothersome. Dyspareunia and vaginal dryness are frequently reported VVA symptoms and often co-occur; however, of recent treatments approved for dyspareunia, none demonstrated a robust statistically significant difference over placebo for the endpoint of vaginal dryness.  

Methods: Postmenopausal women (40-75 years) with ≤ 5% superficial cells on vaginal cytological smear, vaginal pH > 5%, and moderate to severe dyspareunia enrolled in a multicenter, double-blind, placebo-controlled, phase 3 clinical trial and randomized to one of 3 doses of TX-004HR (25 μg, 10 μg, or 4 μg) or placebo. Co-primary endpoints included statistically significant improvement from baseline to Week 12 in vaginal superficial and parabasal cells, vaginal pH, and the severity of dyspareunia (as the most bothersome symptom of VVA). Planned secondary endpoints included assessments of vaginal dryness.

Results: The REJOICE trial enrolled 764 postmenopausal women (mean: 59 years) experiencing moderate to severe dyspareunia at 89 sites across the US and Canada. All 3 doses of TX-004HR demonstrated statistically significant improvement over placebo across all four co-primary endpoints (P ≤ 0.0001 for all doses and coprimary endpoints, except 4 μg dose for dyspareunia, P=0.0255). All 3 doses also demonstrated a statistically significant difference over placebo for vaginal dryness (P ≤ 0.0001 for 25 μg and 10 μg ; P = 0.025 for 4 μg). There were no clinically significant differences in AEs among patients treated with TX-004HR compared to placebo. There were no treatment-related serious AEs reported.

Conclusions: The REJOICE trial demonstrated efficacy and safety of TX-004HR for the treatment of moderate to severe dyspareunia associated with VVA in postmenopausal women. In addition, improvements in a key a priori planned secondary endpoint of vaginal dryness were also statistically significant when compared with placebo for up to 12 weeks of treatment. This investigational applicator-free E2 vaginal softgel represents a potential, new treatment for symptomatic VVA.

Disclosure:

Work supported by industry: yes, by TherapeuticsMD Inc. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

054

The Efficacy of Trigger Point Injections in the Treatment of Sexual Pain
Bahlani-Khanna, S¹; King, A²; Moldwin, R¹
1: The Arthur Smith Institute- North Shore LIJ System, USA; 2: Hofstra- North Shore LIJ School of Medicine

Objective: Chronic pelvic pain (CPP), including pelvic floor dysfunction (PFD) and Category III B prostatitis/ chronic pelvic pain (CP/CPPS), affects up to 40% of patients age 18-45 years. Patients often present with a combination of lower urinary tract symptoms with pelvic pain and sexual dysfunction. Sexual pain is found in up to 42% of women with CPP. No uniform treatment strategy exists for treating these patients.

Often patients with PFD and CP/CPPS will have trigger points. These hyperirritable muscular foci can give rise to pain. Trigger points can be involved in the etiology of sexual pain in women and ejaculatory pain in men. Trigger point injections involve infiltration of the musculature with anesthetic solution (consisting of lidocaine and marcaine), which can be both diagnostic and therapeutic for patients. These injections have been shown to be effective in treating patients with PFD and associated pain. The objective of this study was to further evaluate the role of trigger point injections in treatment of PFD and CP/CPPS, specifically in regards to sexual pain.

Material and Methods: 48 patients with PFD and CP/CPPS were identified via medical record review. Medical records with access to trigger point procedures and data regarding post-procedural symptomatology were reviewed. Results were recorded in a database. Categoric data were compared with the chi-square test; binary data were compared with McNemar’s test. No data was censored. All analyses performed with SPSS v22.0

Results: 48 patients with PFD and CP/CPPS were included. Median age of patients was 47 years [43.1-52.5]. 36 (75%) of these patients are female and 12 (25%) patients are male. 31 patients (64.6%) that received trigger point injections reported improvement in quality of life measures, such as decreases in hesitancy, nocturia, and constipation (all p<0.0001). In total, 22/48 patients reported sexual pain. 12 of 19 female patients with sexual pain reported improvement in sexual pain, including dyspareunia post procedure (p<0.0001). 3 of 3 of male patients (100 %) with ejaculatory pain felt improvement in symptoms post-procedure (p=.25).15/22 patients reported improvement in sexual pain including dyspareunia and ejaculatory pain (p<.0001).

Conclusions: The use of trigger point injections is associated with an overall improvement in quality of life measures and sexual pain in patients diagnosed with PFD and CP/CPPS. This is the first study to evaluate sexual pain in patients after trigger point injections.

Disclosure:

Work supported by industry: no.

055

Pelvic Floor Treatment in a Female Transsexual Patient
Freundlich, O¹
1: Centro Miintimidad, Chile

Objective: Demonstrate the importance of including a pelvic floor physical therapist in the treatment of Sex reassignment surgery 

Material and Method: Female Transsexual patient consulting for impossibility of vaginal penetration after 3 years of Sex reassignment surgery.

The method used for treatment, was pelvic floor muscle exercise to keep normal strength, tone and learn muscle control.

Anatomical education and genitals self exploration to integrate her new vagina to her body scheme

Systematic desenzitation, to normalize genitals sensation.

Vaginal miofascial massage, to keep vaginal elasticity.

Dilators therapy, to avoid vaginal compression and keep the elasticity and learn coital ability.

Results: After 10 sessions of pelvic floor treatment, patient was able to connect with her vagina, localize the pelvic floor muscles, and learn how to relax them, loose the fear of vaginal penetration, and have intercourse without pain, without fear and with pleasure.

Conclusion: Pelvic floor treatment done by a trained pelvic floor physical therapist, can be very useful and helpful to include in the treatment of the female transsexual patients

Disclosure:

Work supported by industry: no.

052

Development of a Harmonized Multi-Site, Prospective Research Registry to Accelerate Evidence-Based Treatment of Sexual Disorders in Women and Girls with Cancer
Lindau, ST¹; Abramsohn, EM¹; Carpenter, K²; Carter, J³; Faubion, S⁴; Feltmate, C⁵; Flynn, K ⁶; Haseotes, D⁷; Jeffery, D⁸; Jhingran, A⁹; Joslin, I¹; Kennedy, V¹⁰; Kushner, D¹¹; Lynn, M¹²; Mumby, P¹²
1: University of Chicago, USA; 2: Ohio State University, USA; 3: Memorial Sloan-Kettering Cancer Center, USA; 4: Mayo Clinic, USA; 5: Dana Farber Cancer Institute, USA; 6: Medical College of Wisconsin, USA; 7: Brown University, USA; 8: Department of Defense, USA; 9: MD Anderson Cancer Center, USA; 10: University of California, Davis, USA; 11: University of Wisconsin, Madison, USA; 12: Loyola University Medical Center, USA

Objectives: To accelerate evidence-based treatment of sexual disorders in women and girls with cancer by creating a harmonized multi-site, prospective research registry.

Material and Methods: A multidisciplinary group of investigators and clinicians affiliated with several NCI-funded and other cancer centers organized at the 4^th meeting of the Scientific Network on Female Sexual Health and Cancer to collaborate on building a harmonized, multi-site prospective registry. Data were collected about the characteristics of existing registries, including self-report measures for assessing sexual function.

Results: As of October 2015, 12 investigators from 10 states and 11 institutions, including 9 NCI-funded cancer centers, were participating in the registry harmonization project. Four institutions had an active registry. Mean registry duration was 2.3 years (range 3 months – 7 years). Total number of registrants affected by cancer (diagnosed with cancer or at elevated risk) was 263 (range 22-148). The oldest registry, established in 2008, was at the University of Chicago (UC). Two sites, UC and University of Wisconsin-Madison, were already harmonized using a REDCap database and protocol developed by UC. The established registries were led by investigators from gynecology (n=2), internal medicine (n=1), and medical oncology (n=1). Six institutions joined the collaborative in order to launch a registry at their site. Thus far, a total of 13 patients at 6 sites have been identified who are interested in a research advocate role. Three investigators with expertise on the PROMIS SexFS and other validated self-report measures have also joined. The four active registries have been administering 15 unique sexuality instruments (including nine PROMIS subscales) evaluating 8 unique domains.

Conclusions: Coordinated research is needed to inform best practices and treatment for a diverse national population of women and girls with cancer and sexual function concerns. A multidisciplinary group is activated to form the first harmonized, multi-site registry in the field. Researchers will convene in December 2015 to align on a core set of domains and measures that all sites will adopt to address the most pressing questions in the field.

Disclosure:

Work supported by industry: no.

041

Self-Reported Sexual Problems Predicts Higher Levels of Depression, Anxiety and Distress in Female Cancer Patients
Hughes, M¹; De La Garza, R¹
1: UT MD Anderson Cancer Center, USA

Objective: The current study was designed to evaluate the prevalence of sexual problems and the extent to which this impacted mood symptoms in cancer patients.

Methods: Only adult female patients seen from July 2014-September 2015 in the MDACC outpatient psychiatry oncology clinic who provided informed consent were included (N=733). Assessment tools include the Patient Health Questionnaire-9 (PHQ-9) to measure depression, the Generalized Anxiety Disorder scale (GAD-7) to measure anxiety, and the NCCN Distress Management Thermometer (DT) and Checklist to measure distress. Demographic variables included age, race/ethnicity, and marital status. Additional categorical variables included cancer diagnosis and psychiatric diagnosis. Data are presented as percentages or Mean ± S.E.M.

Results: In this cohort, 25.3% (186/733) female patients endorsed (Yes vs. No) “sexual problems” on the DT checklist. Patients who endorsed sexual problems were significantly younger (48.9±.8 vs. 53.2±.5, F_1,730=17.7, p<.0001), but there were no differences according to race/ethnicity (χ2=1.4, p=.51). Patients in a committed relationship (married or life partner) were more likely to endorse sexual problems as compared to those who were single, separated, divorced or widowed (31.6% vs. 21.9%; χ2=12.1, p=.0005). Of interest, there were no differences in prevalence of sexual problems according to psychiatric diagnosis (χ2=1.4, p=.51). Importantly, patients who endorsed sexual problems had significantly higher levels of depression (13.1±.4 vs. 10.3±.2, F_1,730=33.1, p<.0001), anxiety (11.6±.4 vs. 9.0±.2, F_1,730=29.3, p<.0001) and distress (6.5±.2 vs. 5.5±.1, F_1,730=17.0, p<.0001).

Discussion: The data indicate that one quarter of all female patients seen at the MDACC Psychiatric Oncology Clinic endorsed sexual problems and that these individuals exhibit significantly greater levels of depression, anxiety and distress. Patients who reported sexual problems tended to be younger and in a committed relationship.

Women who are being treated for cancer are often not evaluated for sexual changes during or after their treatment since the oncologist focuses on treating cancer. Since sexuality is a quality of life issue, it often does not surface until treatments are complete and the patient is in the survivorship stage of her cancer. If a woman complains of depression or anxiety, it is important to also assess for sexual dysfunction. Conversely, if a woman reports sexual problems, she should be assessed for depression and anxiety.

Disclosure:

Work supported by industry: no.

051

The Use of Ilioinguinal Nerve Block for Treatment of Chronic Pelvic Pain
Bahlani-Khanna, S¹; King, A²; Moldwin, R¹
1: The Arthur Smith Institute- North Shore LIJ System, USA; 2: Hofstra- North Shore LIJ School of Medicine

Objectives: Ilioinguinal nerve blockade with administration of local anesthetic has been shown helpful in postoperative analgesia after inguinal surgery and in post-surgical pelvic pain. These blocks are particularly effective in visceral pain states and in sympathetically maintained pain. Ilioinguinal nerve blockade, therefore, has great potential to be an effective element of the management of patients with chronic pelvic pain. The objective of this study was to evaluate the role of ilioinguinal nerve blockade in treatment of chronic pelvic pain (CPP).

Materials and Methods: 37 patients with CPP receiving ilioinguinal nerve block therapy were identified via medical record review. In these patients, ilioinguinal nerve blockade was performed via ultrasound-guided injections of a lidocaine and marcaine cocktail in a 7:3 ratio. Medical records with access to ilioinguinal nerve block procedures and specific questions regarding post procedural symptomatology were reviewed. Results were recorded in a database. Categoric data were compared with the chi-square test. No data was considered censored. All analyses were performed using SPSS version 22.0. 

Results: 37 patients with CPP were included. Median age of patients was 33 years [32.75-54.25]. 22 (59%) of these patients were female and 15 (41%) were male. 19 patients received more than one ilioinguinal nerve block during their treatment course. Average latency to repeat treatment was 53 days, median latency 36 days. 27 (73%) patients were receiving additional concurrent trigger point injections to the pelvic floor. 25 (67.6%) patients reported improvement in pain with ilioinguinal nerve blockade.

Conclusion: The use of ultrasound-guided ilioinguinal nerve block therapy is associated with an overall improvement in pain measures in patients with CPP. It should be considered a safe, valuable, and effective treatment option for this patient population both as stand alone therapy or as adjuvant treatment in patients currently receiving trigger point injections. 

Disclosure:

Work supported by industry: no.

050

Lifetime Persistent Genital Arousal Disorder: Management of PGAD in an Adolescent
King, SA¹; Espenschied, C²; Gagnon, C²; Minton, J³; Goldstein, I¹
1: Alvarado Hospital, USA; 2: San Diego Sexual Medicine, USA; 3: San Diego Sexual Medicine, USA

Introduction: Persistent Genital Arousal Disorder (PGAD) is characterized by persistent or recurrent, unwanted or intrusive, bothersome or distressing feelings of genital arousal or being in the verge of orgasm (genital dysesthesia) not associated with concomitant sexual interest, thoughts or fantasies. PGAD most commonly occurs in sexually active adults, mostly women, who have already experienced sexual desire, arousal and orgasm. PGAD has not been previously reported in an adolescent, naïve to sexual activity, who describes her PGAD as “feelings”. This adolescent has despair, bother, emotional lability and difficulty attending school.

Methods: A 13 year old female, accompanied by her mother, presented with unwanted and unrelenting "feelings" lasting up to an hour at a time, recurring up to 6 times a day, that worsened with anxiety and stress and after swim team, and were unrelated to any known direct injuries to her genital area. She began having "feelings" around age 6 and by age 9 she needed to cross her legs to help relieve symptoms.

Results: MRI of the sacral spine S2-4 ruled out Tarlov cyst. No evidence of genital arousal: lubrication, swelling of clitoris or labia, was noted. She had a significant pain/grimacing response to umbilical hypersensitivity testing. Vulvoscopy revealed pubic hair consistent with Tanner Stage 3. Clitoris and hood were normal, both labia minora met at the posterior fourchette. Minor vulvar vestibular glands at 1, 3, 5, 6, 7, 9 and 11:00 oclock revealed moderate erythema with 8-9, 10, 10, 10, 10, 10 and 10/10 discomfort to cotton swab testing consistent with provoked vestibulodynia. Testosterone was low (9 ng/dl), SHBG 48 nmol/L, calcu-lated free testosterone was low (0.126 ng/dl), dihydrotestosterone was <5 ng/dl, LH was 2.1, FSH was 4.9, estradiol was 37 pg/ml and progesterone was absent. A vestibular anesthesia test (VAT) was performed with topical bupivicaine, lidocaine, tetracaine between Hart’s line and intact hymen. She experienced loss of her “feeling” for the first time and there was a dramatic shift in mood and affect, going from tearful to giddy, happy, joking, and ambulating in the office halls. Local vestibular testosterone 0.1% and estradiol 0.02% cream x 6 months was not successful. Her current diagnosis is congenital neuro-proliferative vestibulodynia. Current management includes tramadol 2.5 mg TID and zolpidem 0.5 mg prn. She is considering complete vestibulectomy in 5 years when she is 18 years.

Conclusion: PGAD in adolescents is a significant clinical challenge.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

049

Changes in the Sexual Self-Schema of Women with a History of Childhood Sexual Abuse Following Expressive Writing Treatment
Pulverman, C¹; Boyd, R¹; Stanton, A¹; Meston, C²
1: University of Texas at Austin, USA; 2: Universtiy of Texas at Austin, USA

Objective: Sexual self-schema are cognitive generalizations about the sexual self that influence the processing of sexually pertinent information and guide sexual behavior. Until recently sexual self-schema were exclusively assessed with self-report instruments. Novel research using the Meaning Extraction Method (MEM), an inductive method of topic modeling, identified seven unique themes of sexual self-schema: family and development, virginity, abuse, relationship, sexual activity, attraction, and existentialism from the sexually-focused essays of 239 (Stanton, Boyd, Pulverman, & Meston, 2015). In the current study, these themes were used to examine changes in theme prominence for women with a history of childhood sexual abuse (CSA) and sexual dysfunction who completed an expressive writing treatment targeted towards improving sexual function.

Materials and Methods: Women (N = 138) with a history of CSA completed a five-session expressive writing treatment. Essays on sexual self-schema written at the pre-treatment intake session and at four post-treatment follow-up sessions were examined for changes in theme prominence.

Results: Women showed a reduction in the prominence of the abuse, family and development, virginity, and attraction themes, and an increase in the existentialism theme.

Conclusions: This study supports the validity of the seven sexual self-schema themes identified by Stanton and colleagues (2105). Specifically, women showed a decrease in their use of the abuse schema after treatment suggesting that expressive writing may aid women with a history of sexual abuse to process their abuse history such that it becomes a less salient aspect of their sexual self-schema. The only schema that increased in prominence after treatment was the existentialism schema, which invokes concepts associated with meaning-making and reflection, and may indicate that the treatment helped women to further reflect on their abuse history.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

048

"Partner Prosthesis Panic": Management of Female Sexual Dysfunction in Partners of Men Undergoing Penile Prosthesis Implantation
Hartzell, R¹; King, SA²; Goldstein, I²
1: San Diego Sexual Medicine, USA; 2: Alvarado Hospital, USA

Objectives: About 30,000 penile implants are placed annually in the US. In our practice, several female partners in monogamous relationships with men with ED considering implant surgery have expressed significant concern over the re-introduction of an erect penis into their sexual lives. We define "Partner Prosthesis Panic” as the concerns of the female sexual partner who described issues such as: her low sexual desire, reduced arousal, muted orgasm, and bothersome pain during penetration. These conditions may negatively influence post-op outcome and frequency of implant use. We examined prevalence of “Partner Prosthesis Panic” and management strategies of distressed female sexual partners of men undergoing penile prosthesis implantation.

Materials and Methods: In the last fifty consecutive penile implant surgeries in men in monogamous relationships, we identified 11 (22%) female sexual partners (mean age 57 +/- 11 years) who expressed “Partner Prosthesis Panic” and underwent management in our facility.

Results: Contemporary management of women with sexual dysfunction is biopsychosocial including judicious use of FDA-approved and non-approved treatment options. 82% were menopausal, 18% were peri-menopausal. All had sexual dysfunction for >5 years prior to the implant. FSFI (mean 18 +/- 4) and FSDS (21 +/- 6) scores were abnormal in all. Psychologic interviews revealed findings consistent with a history of sexual trauma/abuse (27%) and mood issues: anxiety, depression, panic, use of mood-related medications (45%). Pelvic floor exams were abnormal in 73%. Vulvoscopy revealed abnormalities such as clitoral atrophy, resorption of labia minora, erythema/tenderness of minor vestibular glands, limited robust peri-urethral tissue, urethral prolapse, limited gavial rugae, abnormal vaginal pH in all 11 patients. Hormonal assessments of sex steroids were abnormal in all 11 patients. Following sex therapy, physical therapy, and biologic management, 8 of 11 experienced markedly improved sexual function that significantly facilitated couple satisfaction post-penile implantation.

Conclusions: Now that the FDA has approved treatments for women with sexual health concerns, management of women with sexual dysfunction, especially in monogamous relationships with men with ED considering penile implant surgery will become more commonplace. To maximize satisfaction following penile implant insertion, sexual medicine care to both individual members of the couple should be offered and provided.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

047

Review of the Evidence of the Female Prostate as a Functional Gland
Szell, N¹; Goldstein, S²; Komisaruk, B³; Goldstein, I²
1: St. John Providence Health System, USA; 2: San Diego Sexual Medicine, USA; 3: Rutgers Universtiy, USA

Introduction: We have observed women with new-onset internal vaginal orgasmic dysfunction following mid-urethral sling surgery for stress urinary incontinence. We have also reported a meta-analysis of 2350 women in whom there was a large discrepancy noted in orgasm satisfaction versus overall sexual satisfaction following mid-urethral sling placement. We thus propose that mid-urethral slings cause injury to neural pathways to the “female prostate”, as the existence and function of the female prostate is fully supported by extensive reliable contemporary evidence.

Methods: A literature search was performed using "female prostate", "Skene's glands", "paraurethral glands", and "G-spot". Over 200 publications were found, narrowed down based on relevance and analyzed in comparison to the male prostate. Categories included anatomy, physiology, embryology, pathology, neural innervation, adenomatous and cancerous changes, orgasmic potential. Anatomical depictions and imaging studies were included when relevant.

Results: More than 60 publications were included for review and analysis, including critical historic data from Zaviacic, Skene, Grafenberg, and others. Since the time of Kama Sutra, 400 BCE, scholars have proposed the existence of sexually sensitive homologous "female prostate" adjacent to the anterior vaginal wall. Contemporary researchers, however, have characterized “female prostate” exhibiting glandular and secretive elements identical to male prostate via immunohistochemical studies with prostate specific antigen (PSA), prostate specific acid phosphatase, androgen receptors, three dimensional modelling, and waxy casts.

Conclusion: “Female prostate” is embryologically and physiologically identical to male prostate. In some women, stimulation of “female prostate” via the anterior wall of the vagina results in ejaculation and orgasm. This is analogous to stimulation of the rectum resulting in ejaculation and orgasm in some men. The female prostate is not simply a vestigial organ. .

Disclosure:

Work supported by industry: no.

046

Differences in why Women with and without Sexual Dysfunction have Sex
Handy, AB¹; Stanton, AM¹; Kilimnik, C¹; Meston, C¹
1: University of Texas at Austin, USA

Objective: The aim of the current study was to examine whether sexually functional and dysfunctional women differ in the number and reasons for engaging in sex. Based on past research showing sexually healthy women use significantly more cues for engaging in sex than do women with sexual dysfunction (McCall & Meston, 2006), we hypothesized sexually functional women would also have a greater number of reasons for having sex than would sexually dysfunctional women. We also hypothesized there would be differences between sexually functional and dysfunctional women in the reasons they endorsed for having sex. Specifically, sexually functional women would endorse a greater number of Physical reasons for having sex, and sexually dysfunctional women would endorse more reasons pertaining to Insecurity.

Materials/Methods: One hundred and fifty-five sexually functional and dysfunctional women completed the Reasons for Having Sex Questionnaire (YSEX; Meston & Buss, 2007) and the Female Sexual Function Index (FSFI; Rosen et al., 2000). The YSEX assess sexual motivations across four factors (Physical, Goal Attainment, Emotional, and Insecurity), each of which has two to four subscales. Because sexually functional women were significantly younger than dysfunctional women, age was controlled for in subsequent analyses.

Results: Sexually functional women had significantly greater FSFI scores (M = 31.31, SD = 3.47) than did dysfunctional (M = 23.92, SD = 5.55) women (p < .001). There was no difference in total number of reasons between the two groups of women, nor were there differences in number of reasons endorsed on the Physical, Goal Attainment, or Emotional factors. Women with sexual dysfunction endorsed significantly more reasons for engaging in sex on the Insecurity factor, F(1, 151) = 3.929, p = .049. Specifically, we found the Duty/Pressure subscale to be driving this difference, F(1, 151) = 6.928, p = .009. Sexually dysfunctional women also endorsed using Duty/Pressure reasons more frequently than did sexually functional women, F(1, 151) = 8.725, p = .004.

Conclusion: The results speak to the cycle of dysfunction that is often seen in clinical settings, in which the pressure and feelings of duty to have sex lead women to engage in sex that they may not enjoy. These findings suggest that clinicians may need to target this sense of duty to alleviate pressure and encourage enjoyable sex.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

045

An Examination of a Continuous Measure of Subjective Sexual Arousal in Arousal Specificity for Abused and Non-Abused Women
Kilimnik, C¹; Pulverman, C¹; Handy, A¹; Meston, C¹
1: University of Texas at Austin, USA

Objective: Subjective sexual arousal is typically measured via recall using a self-report Likert scale after the presentation of sexual stimuli. This methodology may miss variations in arousal across time during the presentation of different sexual stimuli. The current study examined subjective sexual arousal differences between women with and without a history of childhood sexual abuse (CSA) using both a self-report Likert scale and a continuous measure of arousal. The aim was to examine whether a continuous measure of sexual arousal provides information on the specificity of arousal not detectable using recall self-report measures.

Methods/Materials: Women with a history of CSA that included penetration (n = 38), did not include penetration (n = 20), and with no history of CSA (n = 68) watched erotic film clips (2 minutes of foreplay, 2 minutes of oral sex, and 2 minutes of penetrative intercourse) while continuously reporting on their state sexual arousal using a device that that electronically records changes in arousal as it is slid across intervals (0-7). They then completed a 3-item self-report Likert measure of subjective sexual arousal (Heiman & Rowland, 1983).

Results: There were no observed differences between women in the NSA and CSA groups overall in their subjective arousal across film types using either continuous or Likert Scale measures of subjective sexual arousal. However, differences emerged between groups in subjective arousal specificity across film content. Women who had experienced non-penetrative CSA (M = .62, SD = .30) reported significantly higher subjective arousal to the oral sex film clip than did both the NSA group (M = 55, SD = .29), and the CSA penetration group (M = .45, SD = .29; F_{(2, 120)} = 6.41, p = .002, η_p² = .10).

Conclusions: The use of a continuous measure of arousal during the presentation of sexual stimuli provides more information than retrospective self-report, particularly for arousal specificity. The differences in subjective arousal within the CSA group supports previous findings that characteristics of the CSA events may influence different sexual outcomes (Lemieux & Byers, 2008). The higher arousal of the non-penetrative CSA group may be reflective of the hyper- and hyposexual behaviors reported in women with a history of CSA (Rellini, 2008). Research should explore differences in cognitive, affective, and physiological differences within women with CSA history dependent on the penetrative status of the CSA.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

044

E-Recruitment for Clinical Trials in Sexual Medicine – A Rising Method for a Modern World
Carroll, MS¹; Morin, M¹; Dumoulin, C²; Mayrand, MH²; Waddell, G¹; Khalifé, S³; Bergeron, S²; Dubois, MF¹
1: University of Sherbrooke, Canada; 2: University of Montreal, Canada; 3: McGill University

Objective: Efficient recruitment of participants plays a crucial role in clinical trials and investigators are increasingly tempted toward new e-recruitment initiatives. The aim of this study was to compare the number of patients enrolled, the retention rate and the baseline characteristics of participants recruited using three recruitment methods (E-recruitment, professional referrals and conventional methods)

Material and Methods: The comparison data were collected as part of a bi-centric, parallel group randomized controlled trial evaluating the efficacy of physiotherapy in comparison to topical lidocaine in 212 women suffering from provoked vestibulodynia. The three recruitment methods included: 1) E-recruitment (Facebook ads and Web pages), 2) Health professional referrals (physicians, gynecologists and physiotherapists) and 3) Conventional methods (ads in local newspapers, word of mouth, posters and leaflets in clinics, university, professional schools, restaurants, gyms, etc.). Women interested in participating were screened verbally by telephone and were assessed by one of our gynecologist to confirm their diagnosis. Structured interviews were undertaken to describe their baseline characteristics (age, pain intensity, duration of symptoms, frequency of intercourse, pain at first intercourse and use of oral contraceptive). Chi-square and one-way analysis of variances were used to compare the participants according to their recruitment methods.

Results: Most of the participants were recruited using conventional methods (56.1%) followed by the E-recruitment methods (28.3%) and health professional referrals (15.6%). The retention rate (91-97%) was found to be similar between the three groups (p=0.351). As regards to baseline characteristics, no significant differences were found between the three groups (p≥0.141).

Conclusion: Multiplication of recruitment methods appears beneficial in promoting clinical trial recruitment. Given that the recruitment methods influenced neither retention rate nor patient baseline characteristics, the use of E-recruitment is promising in sexual health trials. An economic analysis is planned to compare cost implication for the different methods.

Disclosure:

Work supported by industry: no.

043

Hormonal and Psychosocial Characteristics of Female Sexual Dysfunction
Wåhlin-Jacobsen, S¹; Pedersen, AT²; Kristensen, E¹; Læssøe, NC¹; Lundqvist, M³; Cohen, AS³; Hougaard, DM³; Giraldi, A¹
1: Psychiatric Center Copenhagen, Denmark; 2: Copenhagen University Hospital, Denmark; 3: Statens Serum Institute, Denmark

Objective: Women’s sexual response is influenced by several inhibitory and excitatory neurophysiological and psychological mechanisms interacting with social and cultural factors. Both neurotransmitters and sex hormones are thought to modulate women’s sexual response and desire. Low levels of testosterone (T) are seen as a risk factor of impaired sexual function, but larger studies investigating the effect of T are missing.

The aim of this study was to investigate how androgen levels and psychosocial factors are associated to Female Sexual Dysfunction (FSD) including Hypoactive Sexual Desire Disorder (HSDD).

Material and Methods: 529 women aged 19-65 years were included in this cross-sectional study. All women filled out a questionnaire including data on psychosocial factors and had a blood test taken on a standardized time in their menstrual cycle. FSD, sexual distress and HSDD was investigated using the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS). Serum levels of T and dehydroepiandrosterone sulphate (DHEAS) were analyzed using mass spectrometry. Logistic regression models were built to test the association between hormone levels and psychosocial factors (explanatory factors) and FSD or HSDD, respectively, and to adjust for relevant confounders. P levels < 0.05 were considered as statistically significant.

Results: DHEAS was associated (p = 0.011) to FSD after adjustment. Relationship length above two years (p = 0.004), and impaired well-being (p < 0.001) were also associated to FSD. T (p = 0.004) and DHEAS (p = 0.028) were associated to HSDD in primary analysis, however after adjustment, only age (p = 0.038), relationship length above two years (p = 0.004), and impaired well-being (p < 0.001) stayed associated to HSDD.

Conclusion: In this large cross-sectional study a statistically significant association between DHEAS and FSD was found, and age was found to associate to HSDD. Relationship length above two years and impaired quality of life were found to associate to both FSD and HSDD.

Disclosure:

Work supported by industry: no.

042

Vagal Activity During Physiological Sexual Arousal in Women With and Without Sexual Dysfunction
Stanton, A¹; Pulverman, C²; Meston, C¹
1: The University of Texas at Austin, USA; 2: The University of Texas at Austin, USA

Introduction: Changes in the high frequency band of heart rate variability (HRV) are due to respiratory sinus arrhythmia (RSA), the cyclical increase and decrease in heart rate that occurs with respiration. RSA is mediated by the parasympathetic nervous system (PNS) through the vagus nerve (Berntson, Cacioppo, & Quigley, 1993). High frequency HRV, indexed by RSA, has been used as a measure of overall PNS activity and the strength of vagal influence on the heart (Berntson et al., 1997; Malik et al., 1996). Recently, HRV has also been associated with female sexual function (Stanton, Lorenz, Pulverman, & Meston, 2015). Low HRV was a significant predictor of female sexual arousal dysfunction and overall sexual dysfunction. Building upon this established relationship between HRV and female sexual function, the present study examined the hypothesis that differences in vagal activity between sexually functional and sexually dysfunctional women may be driving the association between low HRV and female sexual dysfunction.

Objective: To assess vagal activity, indexed by RSA, before, during, and after physiological sexual arousal and to examine potential differences in RSA between sexually functional and sexually dysfunctional women.

Materials and Methods: Sexual function was assessed in 84 women, aged 18-47, with the Female Sexual Function Index (FSFI; Rosen et al., 2000), an empirically validated, 19-item questionnaire. ECG was recorded using Biopac MP150 (Biopac Systems, CA, USA) at a sample rate of 200 samples/sec. Power spectral densities of the beat-to-beat interval variability were determined via the Fast Fourier Transform using Kubios HRV Analysis Software (Biosignal Analysis and Medical Imagine Group, University of Kuopio, Kuopio, Finland).

Results: Significant differences in vagal activity, specifically differences in vagal activity from baseline to the presentation of the erotic stimulus, between sexually functional women and sexually dysfunctional women were observed (p = .02).

Conclusions: Vagal activity, indexed by RSA, during physiological sexual arousal may provide additional specificity to the recently established relationship between HRV and female sexual function while also offering a potential mechanism to target during treatment for sexual dysfunction.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

053

Painful Sex, Why Women Do or Don't Seek Treatment
Kingsberg, S¹; Amadio, J²; Graham, S²
1: U Hospitals Case Medical Ctr, USA; 2: TherapeuticsMD, USA

Objectives: To further understand the reasons why postmenopausal women do or do not use prescription therapy for vulvovaginal atrophy (VVA) and specifically dyspareunia.

Material and Methods: Six in-person focus groups of women diagnosed with VVA and specifically dyspareunia, were held in Tampa, Philadelphia and Chicago from Feb to Mar, 2015. Thirty-eight women participated with a mean age of 62.9 years; 58% were over 60 years of age. The 6 groups were comprised of:a) women currently taking Rx therapy (Rx user = FG=1, n=6); b) women not taking Rx therapy (Rx non-user, FG=3, n=20), and c) a mix of Rx users and non-users (FG=2, n=12).

Results: Women who were not using Rx therapy reported significant pain, loss of sexual function, emotional trauma, lower self-esteem and damage to marital and partner relationships. Statements regarding dyspareunia included: “it felt like someone was stabbing me with a knife”; “it’s sharp – on a 10 point scale, it’s a 10”. Women also reported that the pain can be enduring: “soreness lasts for days after intercourse”; “can’t wipe, it’s irritated and not natural”. Most non-Rx users reported that the experience of sex itself is frustrating with a loss of spontaneity and pleasure.

Attitudes were very different between Rx-users and Rx non-users:

Rx Users: - Recognize physical and emotional benefits of estrogen VVA therapy; - Strong anti-aging beliefs; - Search-out medical advice (switch doctors); - Empowered personality; - Optimistic and sexually active

Rx Non-Users: - Accepting aging as inevitable; - Less likely to talk with healthcare provider, embarrassed;       - Lack of knowledge, fears and confusion dominate thinking; - Depressed about the future; - Not in an active sexual relationship

Conclusions: Based on this sampling of VVA patients, there is a segment of highly motivated patients interested in solutions to the problem of postmenopausal pain with penetration and the underlying condition. However, many of the non-treating women do not understand VVA causes and are not motivated to take action to find help. When they do ask, they are not being heard by practitioners. Women’s perceptions of estrogen are both a barrier to treatment and opportunity for education of the syndrome and options for treatment.

Disclosure:

Work supported by industry: yes, by TherapeuticsMD, Inc. (industry initiated, executed and funded study).

040

Social Media's Impact on PGAD Patients
Cataldo, L¹; Ramsey, K¹
1: PGAD Support for Men and Women - Facebook, USA

Objective: Due to the sensitive and embarrassing symptoms of Persistent Genital Arousal Disorder (PGAD), isolation of PGAD patients is a concern. At present, social media provides much needed information and support for people living with this rare disorder, both nationally and internationally.

Method: Social media on this topic was examined, including PGAD Support for Men and Women, a secret Facebook group, a Yahoo PGAD group- PSAS-support.com, and a recently added YouTube information site. All websites are available for patients seeking in-depth knowledge and support for symptoms of PGAD. We assessed screening procedures for membership, kinds of members and content.

Results: On the Facebook and Yahoo site, potential group members are screened to exclude non-PGAD patients, press and sexual predators. Once members have cleared the screening and are accepted, they are welcomed to a safe, nonjudgmental online space where they have access to a variety of resources. Some healthcare providers are also involved including doctors familiar with treating PGAD, qualified physical therapists, and therapists who are PGAD friendly. Site content includes research articles, member observations/experiences, and alternative treatments that have been successful in symptom management for those who eschew traditional medicine. Most importantly, members are part of a growing, informed and supportive PGAD community.

Conclusions: Online support sites for PGAD sufferers allow willing members to share experiences and support newer members as they navigate lives made even more stressful by PGAD. Additional information is needed for both healthcare providers and PGAD sufferers to better understand and treat the condition, as well as advocacy for it to be recognized.

Disclosure:

Work supported by industry: no.

039

Bringing the Body of the Iceberg to the Surface: the Female Sexual Dysfunction Index-6 (FSDI-6) in the Screening of Female Sexual Dysfunction
Maseroli, E¹; Fanni, E¹; Fambrini, M¹; Ragghianti, B¹; Limoncin, E²; Maggi, M¹; Vignozzi, L¹
1: University of Florence, Italy; 2: University of L'Aquila, Italy

Objectives: Female Sexual Dysfunction (FSD) is a still poorly studied and underdiagnosed condition. The aim of the study was to produce an improved version of FSFI-6 (6-Item Version of the Female Sexual Function Index), entitled FSDI-6 (Female Sexual Dysfunction Index-6), and to estimate its accuracy as a screening instrument for FSD.

Material and Methods: In the new version, an item related to the personal interest in having a satisfying sex life was added, while the item rating the entity of sexual arousal was removed. We administered FSDI-6 in a consecutive series of female adult patients not consulting for sexual problems (n=120, Cohort 1), and in another series of patients specifically consulting for sexual problems, which were considered as the control group (n=160, Cohort 2).

Results: FSDI-6 score was significantly higher in patients in Cohort 2 (p<0.0001). Cronbach’s alpha for FSDI-6 was 0.784, indicating a high level of reliability. The estimated area under the ROC curve for FSDI-6 was 0.657 (p< 0.0001, 95% CI 0.584- 0.730). The proportion of subjects with a pathological FSDI-6 score (≥16.5) was 29.9

(n=32) and 59.4% (n=95) in Cohort 1 and 2, respectively (p<0.0001). Among subjects with a pathological FSDI-6 (score≥16.5), those consulting for FSD had been postmenopausal for fewer years, had a higher level of education, a lower BMI and a lower prevalence of chronic diseases than those not consulting for FSD (p<0.05).

Conclusions: Although a lower educational level, overweight/obesity, menopause and chronic diseases are risk factors for FSD, they are often associated with the failure in medical consultation for FSD. We propose that FSDI-6 should be performed by health care providers in non-specialist settings in order to detect potential FSD, which otherwise could remain under-diagnosed.

Disclosure:

Work supported by industry: no.

038

Female Survivors of Sexual Abuse: Do they Differ in Sexual Behavior, Attitudes, and Perceptions towards Sexuality? Findings from a Cross-Sectional Survey Conducted among University Students in Lebanon
El Kak, F¹; El Salibi, N¹; Yasmine, R¹; Ghandour, L¹
1: American University of Beirut, Lebanon

Objectives: Myths and misconceptions about sexual abuse place an added burden on women through negative attributions and social stigmatizations. This study aims to investigate whether female university students who reported sexual abuse vary in their sexual practices, attitudes, and perceptions from those who did not (adjusting for socio-demographics).

Materials and Methods: A cross-sectional anonymous online survey was conducted between April-August 2012 among undergraduate and graduate females (aged 18-30) attending the 4th largest private university in Lebanon.

Results: One in five females (21%) reported lifetime sexual abuse. Compared to females with no history of sexual abuse, female survivors were 2-3 times as likely to report penetrative sexual experiences (p<0.0001), but were equally likely to report ever engaging in oral or anal sex to avoid hymen-breaking. Survivors of sexual abuse were more likely to report engaging in sexual activities they did not really want to (OR=7.44, p <0.0001), coercion at sexual debut (OR=3.42, p <0.0001), and ever being in a relationship where things were moving too fast physically (OR=2.57, p <0.0001). Reported reasons for engaging in sexual intercourse were similar for both groups whereby 68% would have sex if they are going to marry their partner and 87% would do so if they had a partner they loved and were comfortable with. Both female groups were also equally likely to agree that sexual intercourse is an intimate experience (94%) and that only two people who trust each other completely should have sexual relations (81%).Reasons for delaying sexual debut were also similar where the majority reported that it is against their belief or religion (75%), that their parents would disapprove (76%), or felt concerned about their reputation, losing self-respect, feeling guilty, or social repercussions (67%).

Conclusions: Contrary to social misconceptions, our findings suggest that survivors of sexual abuse do not necessarily have more open practices and views about sexuality. Understanding gender norms and breaking sex role stereotyping is crucial to prevent sexual abuse and victim blaming and enable survivors to reach out for support and counselling.

Disclosure:

Work supported by industry: yes, by Ford Foundation (industry funding only - investigator initiated and executed study).

037

Effects of Physical Therapy on Female Dyspareunia in Japan
Shigeta, M¹; Sekiguchi, Y¹; Nakamura, R²
1: Japan; 2: , Japan

Objectives: The purpose of this study was to investigate effects of the physical therapy on female dyspareunia in Japan. Women who have dyspareunia or vaginismus have hyperactivity / hypertonia of the pelvic floor and it’s called an OVERACTIVE PELVIC FLOOR. Physical therapy reduced their chronic vulvar pain more than half on 71 % of women. 62 % improved their sexual lives and 50 % on their Quality of life. (Hartmann D. et al. 2001).And also the women with strong pelvic floor muscles were higher score of Female Sexual Function Index questionnaire (FSFI) (Lowenstein L. et al. 2010).However physical therapy hasn’t been known and done as a treatment on female dyspareunia in Japan.

Materials and Methods: Nineteen women (mean age 43.3 +/- 10.0 years) who had dyspareunia visited our clinic between April 2011 and March 2015 were evaluated by the validated Female Sexual Function Index questionnaire (FSFI), Visual Analog Scale (VAS) which is for patient’s satisfaction and Oxford Grading Scale (OS) which is for patient’s pelvic floor muscles strength. We compared the first from the last evaluations. The Patients were underwent progressive muscle relaxation method, myofascial release of pelvic floor muscles, internal soft tissue mobilization and massage treatment, pelvic floor muscles strengthening, and systematic desensitization therapy with vaginal dilators by a physical therapist. And the physical therapist suggested some home programs such as self-massage, stretching and strengthening of pelvic floor muscles with dilators or fingers of themselves.

Results: The average from all evaluations significantly improved after physical therapy (p<0.05) .Total score of the FSFI was up 8.4, desire 0.7, arousal 1.3, vaginal lubrication 1.4, orgasm 1.1, satisfaction 1.6, pain 2.3. The VAS mean first 93.2 +/- 6.7 → after 41.1 +/- 23.8, The OS mean first 2.5 +/- 1.0 → after 3.6 +/- 0.8.

Conclusions: In this study, the treatments with enough counseling, systematic desensitization and Physical therapy may contribute to improve female dyspareunia. Pelvic floor disorders of hyperactive type causally related to sexual pain disorders may affect the sexual response (Graziottin 2000). Therefore physical therapists should be part of the multidisciplinary team such as sexologists, gynecologists, urologists and psychologists involved in the center of sexual medicine.

Disclosure:

Work supported by industry: no.

036

A Review of Treatment Options for Compromise of Vaginal Tissue Integrity (Vaginal Laxity)
Krychman, ML¹; Wilkerson, D²
1: Southern California Center for Sexual Health and Survivorship Medicine, Inc.; 2: Senior Director, Clinical Affairs, Viveve, Inc.

Introduction: Vaginal tissue architecture and laxity has often been overlooked as contributing etiological factor to female sexual dysfunction. Vaginal looseness can lead to diminished physical sensation during intercourse. This reduction in sensation is often coupled with a reduction in sexual satisfaction, which can also impact a woman’s relationship with her sexual partner.

Methods: A comprehensive PubMed review was performed with key words: vagina/laxity/sexual function or vagina/loose/sexual function. A total of 15 English articles were assessed.

Results: The following treatment options were mentioned in the scientific literature and a benefit/risk assessment of each will be presented. Over-the-Counter (OTC) Vaginal Tightening Products: OTC products remain unregulated, may severely disrupt the vaginal ecosystem, and often have unsubstantiated claims. Behavioral Modification: Pelvic floor physical therapy exercises, including Kegel exercises, have often been viewed as a noninvasive mainstay treatment for vaginal laxity, however they are time consuming and have poor patient compliance and limited efficacy. Office-Based Outpatient Radiofrequency Intervention: Two published clinical studies for treatment of vaginal tissue to improve laxity and sexual satisfaction; 30 minute office-based, minimally-invasive procedure. Surgical Correction: Surgery is an invasive approach, which can include a substantial recovery period, and potential for serious adverse effects (e.g., suburethral trauma).

Conclusion: Vaginal tissue integrity can directly impact sexual function. There are limited clinically proven, safe and effective treatments. A nonablative, in-office targeted radiotherapy with cooling treatment of the vaginal introitus shows excellent promise for safe and effective treatment for this currently unmet medical need. 

Disclosure:

Work supported by industry: yes, by Viveve, Inc.. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

035

Prevalence and Motivation for Pubic Hair Removal among Women in the United States
Rowen, TS¹; Gaither, TW²; Awad, MA²; Osterberg, C²; Shindel, AW²; Breyer, BN²
1: Department of Obstetrics, Gynecology and Reproductive Sciences. University of California, San Francisco; 2: Department of Urology. University of California, San Francisco

Background: Pubic hair grooming is an increasingly prevalent trend. Several studies have sought to characterize its prevalence, associated demographics and motivations. This national study enrolled a representative sample of women to characterize current grooming practices in the United States. 

Methods: A nationally representative survey of noninstitutionalized adults aged 18–65 residing in the United States was collected. We developed a questionnaire examining grooming habits. Analysis focused on demographic characteristics and motivations associated with grooming.

Results: A total of 3316 women were included in the analysis, of which 2778(83.8%) reported genital grooming and 538 (16.2%) reported never grooming. On bivariate analysis grooming was associated with younger age, Caucasian race, higher education/income, and more sexual activity. On multivariate analysis only age, race, education and partner preference were associated with grooming. There was no association between type of relationship or sexual activity and grooming.

Conclusion: This study is the first of its kind to provide a nationally representative assessment of contemporary female genital grooming habits. We found demographic differences in grooming which may reflect cultural variations in preference related to pubic hair. Healthcare providers can use this information to better counsel patients and understand grooming practices.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

033

Sexual Diversity in the United States: Results from a Nationally Representative Survey
Herbenick, D¹; Dodge, B¹; Bowling, J¹; Sayegh, MA¹; Sanders, SA¹
1: Indiana University

Objectives: To document, among a nationally representative sample of adult women and men, a broader range of adults’ sexual behaviors and interests.

Methods: A cross-sectional, Internet-based, US nationally representative probability survey of 2,021 adult women (n = 1046) and men (n = 975). Participants reported on demographic items, lifetime and recent sexual behaviors, and rated the appeal of 50+ sexual behaviors.

Results: Most participants (>80%) reported lifetime masturbation, vaginal sex, and oral sex. Lifetime anal sex was reported by 43% of men (insertive) and 37% of women (receptive). Common lifetime sexual behaviors included wearing sexy lingerie/underwear (75% women, 26% men), sending/receiving digital nude/semi-nude photos (54% women, 65% men), reading erotic stories (57% of participants), public sex (≥43%), role-playing (≥22%), tying/being tied up (≥20%), spanking (≥30%), and watching sexually explicit videos/DVDs (60% women, 82% men). Threesomes (10% women, 18% men) and playful whipping (≥13%) were less common. Lifetime group sex, sex parties, taking a sexuality class/workshop, and going to BDSM parties were uncommon (<8%). More Americans identified many behaviors as “appealing” than had engaged in them. Romantic/affectionate behaviors were among those most commonly identified as appealing.

Conclusions: Findings add to our understanding of more diverse U.S. adult sexual behaviors and the appeal of a range of sexual behaviors. For practitioners and providers, this information may assist in meeting the needs of diverse populations including improved information exchange and educational efforts.

Disclosure:

Work supported by industry: no.

028

Sexual Cognitions in the Real World: Quantifying and Comparing Sexual Self-Schemas in a Large Online Sample
Stanton, A¹; Boyd, R²; Meston, C¹
1: The University of Texas at Austin, USA; 2: The University of Texas at Austin, USA

Introduction: In a recent study, the meaning extraction method (MEM; Chung & Pennebaker, 2008), an advanced computerized text analysis technique that extracts themes from natural language, was used to analyze women’s sexual self-schemas (Stanton, Boyd, Pulverman, & Meston, 2015). Participants completed open-ended essays about their personal feelings associated with sex and sexuality in the laboratory. Seven unique themes relevant to sexual self-schemas were extracted from these essays: family and development, virginity, abuse, relationship, sexual activity, attraction, and existentialism. The present study compares the themes extracted from the expressive essays written in the laboratory with themes that were extracted from posts on sex-related boards of a large online forum. Furthermore, Stanton and colleagues (2015) observed significant differences in sexual self-schemas based on sexual abuse history; non-sexually abused (NSA) women were more likely than women with histories of childhood sexual abuse (CSA) to invoke the virginity and the relationship themes in their sexual self-schemas, while CSA women were more likely to invoke themes of abuse and attraction than their non-abused counterparts. The present study also compares the differences in sexual self-schemas between NSA women and women with a history of CSA that emerged in the laboratory setting with those that emerged in the online forum.

Objectives: (1) To compare sexual self-schemas extracted from real-world online forums to sexual self-schemas that were extracted from expressive writing samples in a laboratory study; (2) to compare the differences in sexual self-schemas between NSA and CSA in the laboratory study to differences in sexual self-schemas in the online forum.

Materials and Methods: Sexual self-schemas were assessed via the MEM in 6,089 online posts across four different sex or sexual-abuse relevant online forums.

Results: The seven original sexual self-schema themes determined by Stanton and colleagues (2015) were validated, and several new themes emerged. As in the laboratory study, posters in non-abuse specific forums were more likely than posters in the abuse-specific forums to invoke the virginity theme (F = 20.947, p < .000, η² = .003). Similarly, posters in the abuse-specific forum were more likely than posters in the non-abuse specific forums to invoke the theme of abuse (F = 2833.272, p <.001, η² = .318) and the theme of attraction (F = 8.579, p = .003, η² = .001). Effect sizes ranged from small to large.

Conclusions: Sexual self-schemas have been studied extensively in the laboratory, but they have never been studied in a large online sample. To our knowledge, these results provide the first empirical examination of sexual cognitions in the real world.

Disclosure:

Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

029

Prevalence of Sexual Difficulties among Premenopausal Women: A Systematic Literature Review and Meta-Analysis
McCool, M¹; Zuelke, A²; Theurich, M³; Knuettel, H⁴; Ricci, C⁵; Apfelbacher, C¹
1: University of Regensburg, Germany; 2: Friedrich Schiller University of Jena, Germany; 3: Ludwig Maximilian University of Munich, Germany; 4: University Library of Regensburg, Germany; 5: Internationa Agency for Research on Cancer, France

Objective(s): To provide an estimate of the prevalence of sexual difficulties among premenopausal women worldwide

Material and Method(s): Observational studies which assessed the prevalence of sexual difficulties among premenopausal women in the general population were systematically sought in relevant databases (Jan 2000-July 2014). Publications which reported the prevalence rate for at least one sexual difficulty were included. A meta-analysis of prevalence rates was performed as well as stratification by factors of study design.

Result(s): After screening 9292 results, 440 publications were retrieved for full text review. Of these, 135 studies were included in the systematic review. Wide ranges of prevalence were found in the literature: sexual desire difficulties 6% to 70%, sexual aversion 5% to 24%, sexual arousal difficulties 1% to 60%, lubrication difficulties 1% to 53%, orgasm difficulties 8% to 72%, and coital pain 1% to 72%. The meta-analytical estimate of included studies showed that 40.9% of premenopausal women report sexual difficulties (95% CI: 37.1;44.7, I²=99.0%). Prevalence estimates of the individual sexual difficulties ranged between 20.6% (lubrication difficulties) and 28.2% (sexual desire difficulties). Further subgroup analyses showed significantly higher prevalence rates of sexual difficulties in Africa; studies performed in countries with gender-equal sexual regimes had significantly lower rates of sexual difficulties. Higher rates of sexual dysfunction were reported in studies which used interviews and questionnaires together to collect data. The validity of the assessment tool was examined, resulting in significantly higher prevalence rates in studies using non-validated tools. Prevalence rates in studies with pharmaceutical funding were lower in all domains – in some cases, significantly lower. No evidence for publication bias could be indicated through Begg’s rank correlation test and Egger’s correlation test.

Conclusion(s): Individual prevalence rates of female sexual difficulties vary substantially, worldwide. Meta-analytical estimates show that 2 out of 5 premenopausal women report sexual difficulties, posing a substantial public health problem. Still, more research and improved standardization are needed in this field.

Disclosure:

Work supported by industry: no.

030

Which are the Male Factors Associated with Female Sexual Dysfunction (FSD)?
Maseroli, E¹; Fanni, E¹; Mannucci, E¹; Fambrini, M¹; Jannini, EA²; Maggi, M¹; Vignozzi, L¹
1: University of Florence, Italy; 2: Tor Vergata University of Rome, Italy

Objectives: It has been generally assumed that partner’s erectile dysfunction (ED), premature (PE) and delayed ejaculation (DE) play a significant role in determining Female sexual dysfunction (FSD). The present study aimed to evaluate the role of perceived male partner’s sexual function in determining FSD.

Material and Methods: A consecutive series of 156 women consulting our clinic for FSD between January and December 2014 was retrospectively studied. All patients underwent a structured interview and filled out the Female Sexual Function Index (FSFI).

Results: No significant association was observed between FSFI total score and cardiovascular risk factors or investigated metabolic parameters. When relational parameters were evaluated, FSFI total score decreased as a function of partner’s age, conflicts within the couple, a relationship without cohabitation and the habit of engaging in intercourse to please the partner (p<0.05); FSFI total score increased as a function of frequency of intercourse, attempts to conceive and fertility-focused intercourse (p<0.05). FSFI total score showed a negative, stepwise correlation with partner’s perceived hypoactive sexual desire (HSD) (r=-0.327; p<0.0001), whereas no significant correlation was found between FSFI and ED, PE or DE. In an age-adjusted model, partner’s HSD was negatively related to FSFI total score (Wald=9.196, p=0.002), and arousal (Wald=7.893, p=0.005), lubrication (Wald=5.042, p=0.025), orgasm (Wald=9.293, p=0.002), satisfaction (Wald=12.764, p<0.0001) and pain (Wald=6.492, p=0.011) domains. Partner’s HSD was also significantly associated with somatized anxiety, low frequency of intercourse, low partner’s care for the patient’s sexual pleasure and with a higher frequency of masturbation, even after adjusting for age (p<0.05). In patients not reporting any HSD, FSFI total score was significantly lower when their partner’s libido was low (p=0.041); the correlation disappeared if the patient also experienced HSD.

Conclusions: Partner’s performance during sexual intercourse is not a main determinant of FSD; conversely, women’s sexuality is mostly impaired by the perceived reduction of their partner’s sexual interest.

Disclosure:

Work supported by industry: no.

031

The Impact of Mastectomy Type on the Female Sexual Function Index (FSFI) and Parameters of Intimacy such as Appearance, Satisfaction, and the Breast’s Role in Intimacy
Rojas, K¹; Raker, C¹; Onstad, M ²; Kunkel, E³; Clark, M ⁴; Stuckey, A¹; Gass, J ¹
1: Women & Infants' Hospital/Brown University, USA; 2: MD Anderson Cancer Center; 3: Perelmen School of Medicine at the University of Pennsylvania; 4: Warren Alpert Brown School of Medicine

Objective: We have previously demonstrated that parameters of intimacy such as appearance, satisfaction, and the preservation of the breast’s role in intimacy in breast cancer patients were significantly positively associated with a higher median Female Sexual Function Index (FSFI). In this study, we sought to explore the impact of mastectomy type on these parameters and FSFI.

Material and Methods: A cross-sectional survey with a retrospective chart review included patients at least one year from primary breast cancer surgery. The survey included the FSFI, seven investigator generated questions focusing on the operated breast during intimacy, and seven demographic questions. Sexual dysfunction was identified as an FSFI score <26.55. The survey questions were compared using Chi-square and Kruskal-Wallis tests. Demographic information, tumor type, treatment course, and survey responses between three mastectomy groups: simple/modified radical (TM), skin-sparing (SSM), and nipple-sparing (NSM) were compared.

Results: Two hundred sixty-eight patients participated. Median age was 57 (range 30-93); 77.2% of respondents were post-menopausal. Thirty eight patients (46.3%) had TM, 36 (44.4%) had SSM, and 8 (9.8%) had NSM. Satisfaction with appearance of the chest postoperatively was not significantly different between groups. Sixteen of the 38 TM patients (42.1%) and all SSM and NSM patients were reconstructed. Those who underwent SSM had significantly greater FSFI satisfaction domain scores (median 5.20) than women who underwent TM with reconstruction (median 4.40) or NSM (median 4.80) (p=0.005). There was a decrease in the importance of the role of the chest in sex and intimacy in surgical groups pre- and postoperatively; and this was more dramatic in the TM group (89.2% to 58.8%) when compared to SSM and NSM combined (93.3% to 77.8%) (p=0.09).

Conclusions: Patients who underwent SSM did have significantly higher satisfaction domain scores of the FSFI. Interestingly, there was no significant difference in patient satisfaction with appearance of the chest between mastectomy groups. TM patients did have a more dramatic decrease in the importance of the chest pre- and postoperatively but this did not reach significance. Surgeons may consider these outcomes when setting expectations with patients regarding surgical treatment. However, given our small numbers, the impact of the preservation of the nipple specifically remains to be further investigated.

Disclosure:

Work supported by industry: no.

032

Effects of Pornography Use on the Couple Relationship: Results of “Bottom-Up,” Participant-Informed, Qualitative Research
Fisher, W¹; Kohut, T¹; Campbell, L¹; Montgomery Graham, S¹
1: Western University, Canada

Objective: Considerable research has emerged concerning effects of pornography on couple relationships. “Top-down” close-ended quantitative investigations have targeted a limited number of primarily harm-focused effects for study. A small body of qualitative research offers tantalizing glimpses of potential effects that have been overlooked in “top-down” close-ended quantitative research. The aim of the current “bottom-up” participant-informed, qualitative research was to identify a range of participant reported effects of pornography use on couple relationships that have been overlooked in “top-down,” close-ended, quantitative studies.

Materials and Methods: An online survey recruited men (n = 219) and women (n = 211) who were currently in a heterosexual relationship where at least one partner had experience with pornography use. Open-ended questions probed participants’ perceptions of the impacts that their solitary pornography use, their partners’ solitary pornography use, and/or their shared pornography use, has had on their relationships. Responses were analyzed using Thematic Analysis (Braun & Clarke, 2006).

Results: Thematic Analysis identified 66 distinct themes related to impact of pornography use on the couple relationship. The most common reported effect of pornography on the couple relationship was “no negative effect,” and reported positive effects including “source of sexual information,” “increased sexual experimentation,” “improved sexual communication,” and “enhanced couple intimacy” predominated, together with less frequently reported negative effects of pornography, including “created unrealistic expectations” and “sexual insecurity.”

Conclusions: In “bottom-up” participant-informed, qualitative research pornography consumers and their partners reported a broad range of perceived effects of pornography use on their relationships including, modally, “no negative effects,” and predominantly positive effects. These salient reported effects may contribute to shaping the direction and focus of research in this area.

Disclosure:

Work supported by industry: no.

034

FC2 Dual Protection Non-Hormonal, Latex Free Female Condom
Faught, B¹; Goldstein, I²; Martens, M³; Rodriguez, K⁴; Ostrowski, S⁴; Levin, L⁴
1: Women’s Institute for Sexual Health; 2: Alvarado Hospital; 3: Jersey Shore University Medical Center, Rutgers-Robert Wood Johnson School of Medicine; 4: The Female Health Company

Objectives: Use of male condoms for contraception and STI protection can be associated with a lack of control for women, decreased pleasure for women and their sexual partners, and negative reactions to latex. The objective of this study was to survey and interview women with regard to use of the only FDA and WHO approved class III medical device, the FC2 Female Condom. The FC2 has the dual indication for preventing pregnancy and HIV/AIDS and other STIs.

Materials and Methods: This study involved an online survey and was conducted on two all women audiences. The first audience were condoms/short term hormonal contraceptive users who volunteered to switch to FC2 during a 6-month trial period. The second audience was independent online purchasers of the FC2. Fifteen responses came from the independent purchasers and 19 came from the focus group participants.

Results: Respondents identified as 67% Caucasian, 9% Hispanic or Latino, 9% Black, 6% American Indian or Alaskan Native, 6% Asian and 3% did not want to identify. Independent purchasers were age 25-64, and focus group respondents were age 22-45. Thirty-two percent were single, 59% were in a long term relationship, and 9% were married. Of the questions asked, women responded positively to, “Overall how well did you like the FC2 female condom?” (71 %); positively or neutrally to, “How easy was it to use the FC2 female condom?” (82%). Among attributes respondents agreed with were: “Is an effective form of contraception” (85%); “Allowed me to take control of my own protection” (79%); “Made me feel protected” (71%); “Made me feel good about my contraceptive choice”(65%); “Stays in during sex” (62% positive and 29% were neutral); “Improved the feeling/pleasure of sex” (21% with 32% neutral); “Felt more natural for my partner than male condom” (41%); and “Allowed spontaneity” (47%). Forty-seven percent of survey respondents reported purchasing FC2 multiple times, 47% would buy it again within 6 months, and 82% would recommend it to others.

Conclusions: While barrier contraceptives are most often used by males, the FC2 Female Condom offers an internal female condom that provides a non-hormonal, latex free option for dual protection against HIV/STI’s and unplanned pregnancy. This study indicated a positive acceptance by a majority of women, and counseling regarding its indications and availability should be provided in discussions with female patients.

Disclosure:

Work supported by industry: no.