Baseline Female Sexual Function Index Research Articles

Efficacy of in-office lysis of clitoral adhesions with excision of keratin pearls on clitoral pain and sexual function: a pre-post interventional study.

Keratin pearls are foci of central keratinization within concentric layers of squamous cells that can form under the clitoral prepuce and cause pain (clitorodynia); in-office removal of keratin pearls may reduce clitoral pain and improve sexual function. This study aims to investigate clitoral pain and sexual function in women with partial clitoral phimosis and keratin pearls before and after in-office lysis of clitoral adhesions with keratin pearl excision (LCA-KPE). A pre-post interventional study evaluated patients who underwent LCA-KPE between January 2017 and February 2023 in 2 metropolitan gynecology clinics specializing in vulvar pain. Patients presenting with keratin pearls and partial clitoral phimosis identified through retrospective chart review were asked to complete postprocedure questionnaires and provide subjective responses on clitoral discomfort, sexual function, sexual distress, and their experience with in-office LCA-KPE. Bivariate analyses with paired t tests were conducted to determine the effect of LCA-KPE. Qualitative data were analyzed with thematic coding. An 11-point pain visual analog scale was utilized to determine pre- and postprocedure clitoral discomfort and difficulty with orgasm. Female sexual dysfunction was measured with the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised. A total of 32 of 74 patients who met inclusion criteria completed postprocedure surveys (43% response rate). Mean clitoral pain for respondents was 6.91 at baseline and 2.50 after LCA-KPE (P < .001). Mean difficulty with orgasm was significantly decreased from 5.45 at baseline to 3.13 after LCA-KPE (P < .001). Participants had a mean FSFI total score of 17.68 after treatment compared with a mean total baseline FSFI of 12.12 (P = .017). The mean FSFI score for pain was 2.43 at follow-up compared with 1.37 at baseline (P = .049). There was no significant difference in the mean Female Sexual Distress Scale-Revised score before vs after the procedure (P = .27). Qualitative themes described the procedure as painful but worthwhile, with 77% of participants reporting the overall experience as positive. Recurrence rate overall was 28%, with a median of 2 repeat procedures. Recognizing keratin pearls as a structural cause of clitoral pain and offering in-office treatment is an important tool in addressing clitorodynia and improving sexual function. This is the largest study to date documenting the occurrence, identifying associated pain conditions, and evaluating procedural outcomes for clitoral keratin pearls. This study was limited by a relatively small sample size. In-office LCA-KPE significantly reduced clitoral discomfort and difficulty with orgasm.

Effects of onabotulinum toxin-A injection on sexual function in women with refractory interstitial cystitis/bladder pain syndrome: A prospective study.

To determine the effect of intravesical onabotulinum toxin-A (BoNT-A) treatment on sexual functions in female patients with refractory interstitial cystitis/bladder pain syndrome (IC/BPS). Female patients with IC/BPS refractory to previous treatments were included in the study between January 2020 and April 2022. Patients were treated with the trigone-sparing injection (Group 1) or trigone-included injection (Group 2) techniques. 100 Units of BoNT-A was applied submucosally on 20 different points. The patients were evaluated with visual analog scale (VAS), O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI), Interstitial Cystitis Problem Index (ICPI), Female Sexual Function Index (FSFI) questionnaires, 3-day voiding diary, uroflowmetry, and post-voiding residual volume analysis in the preoperative period, as well as on the 30th and 90th days postoperatively. For the repeated measurements, analysis of variance was used to assess the time-dependent variation across groups. The baseline FSFI score of the patients was 15.96 ± 3.82. Following the treatment, the FSFI scores were 22.43 ± 4.93 and 24.41 ± 5.94 on the 30th and 90th days, respectively (p < .001). We observed statistically significant improvement in all FSFI subdomains (p < .05). Statistically significant improvements with treatment on ICSI, ICPI, and VAS scores were achieved (p < .05). Preoperative FSFI scores were similar in Group 1 and Group 2 (p = .147). While the preoperative FSFI scores were 17.00 ± 3.73 and 14.84 ± 3.72 for Group 1 and Group 2, respectively, the scores after the treatment were 22.85 ± 5.01 and 21.98 ± 5.01 on the 30th day, and 24.62 ± 6.06 and 24.19 ± 6.05 on the 90th day postoperatively. Significant improvement was observed in FSFI scores with treatment, and no difference was observed between the two groups in terms of treatment response (p = .706). Intravesical BoNT-A injection in the treatment of women with refractory IC/BPS improves sexual functions. It also significantly improves pain and symptom scores. Both trigone-sparing and trigone-including injections are similarly safe and effective.

Effect of COVID-19 on sexual function and activities among reproductive-age women in Ibadan, South-West Nigeria.

Since the outbreak of COVID-19 disease, the environment, families, individuals, and their ways of living have been affected. Social distancing was one of the strategies for the prevention of SARS-CoV-2 infection. It led to limited social interactions for fear of contracting the infection, which ultimately affected relationships, among which is sexual health. To determine the risk of female sexual dysfunction and the effect of the COVID-19 pandemic on sexual function and activities among women of reproductive age in Ibadan, South-West Nigeria. This cross-sectional study of 218 reproductive-age women evaluated the sexual function before, during, and after the COVID-19 disease pandemic and lockdown. Pretested semistructured self-administered questionnaires with the Female Sexual Function Index (FSFI) were used for data collection. Information collected included sociodemographic and gynecologic characteristics and COVID-19 experiences, as well as sexual history and function before, during, and after the COVID-19 pandemic lockdown. The level of significance was set at P < .05. Respondents were aged 20 to 50years (95%) with a mean ± SD age of 34.82 ± 8.52 years; the majority were married (75.58%); one-fifth (21.9%) tested positive for COVID-19 infection; and participants who tested positive for COVID-19 infections were mostly health care workers. An absence of sexual activity was reported in 9.18% of participants during lockdown, 7.73% before lockdown, and 4.18% after lockdown. The risk of female sexual dysfunction was prevalent among participants, especially those who tested positive for COVID-19 infection. The prevalence was worse during the pandemic lockdown (53.57%) than before (48.39%) or after (51.61%), and a similar pattern was seen among those who tested negative. There was no statistically significant difference in risk of developing sexual dysfunction during the COVID-19 pandemic between those who tested positive and negative to COVID-19. The arousal and desire domains contributed the highest proportion of low FSFI scores. Nationwide lockdowns, which may be a method of control for pandemics, may result in psychosocial complications such as female sexual dysfunction. Most respondents had tertiary education and were able to respond to self-administered questionnaires, yet the risk of recall bias remains a concern whereas the pandemic met the world unprepared and baseline FSFI prior the pandemic was not available for participants. There are no local validation studies for the FSFI in Nigeria, which could have aided interpretation of results. A low FSFI score is prevalent in Ibadan, South-West Nigeria, with a higher incidence reported during the COVID-19 pandemic lockdown.

(013) More Than Just “Vaginal Dryness”: Addressing an Unmet Need for Sexual Health Intervention in Female Cancer Survivors

Abstract Introduction Female sexual dysfunction (FSD) in cancer survivors is underreported and therefore undertreated. While the impact of cancer treatment on sexual health has been investigated through validated patient-reported outcomes, little work has been done to describe genitourinary anatomical changes in women in this population and how these changes relate to sexual function. Objective This study aims to 1) describe the population of female cancer survivors seeking treatment for sexual dysfunction through a novel sexual health after cancer program and 2) correlate disruptions in genitourinary exam findings to patient-reported sexual function. Methods A retrospective analysis included patients presenting to a sexual health after cancer program at a cancer center in South Florida. Patients received a baseline Female Sexual Function Index (FSFI) and underwent a physical, including abdominopelvic, exam. The FSFI is a validated 19-item survey that assesses desire, arousal, lubrication, orgasm, satisfaction, and pain domains. A total FSFI≤26.55 indicates sexual dysfunction. Genitourinary exam changes were characterized using a novel Adapted Vulvovaginal Exam Score (AVES) which assesses vaginal rugae, vascularity, epithelial integrity, elasticity, and dryness. A high AVES (&amp;gt;3) corresponds to more severe exam disruptions. Mean FSFI total and domain scores were compared between AVES groups (0-3 vs. &amp;gt;3) using t-test. A multivariate binary logistic regression model was fit to identify significant patient factors, treatment characteristics, and FSFI responses associated with high AVES score. Adjusted odds ratios (aOR) and corresponding 95% confidence intervals (95%CI) were calculated. Results Between 2020-2021, 139 female cis-gender women with a median age of 46 (range 19-70) at diagnosis were seen in the MUSIC Program that 56.8% identified as Hispanic/Latinx. Most were treated for breast (79.1%) or gynecologic (9.4%) cancer. Common presenting symptoms included vaginal dryness (55%), painful sex (45%), low desire (36%) and hot flashes (22%). Patients who disclosed details about pain (n=62) reported penetration was possible but uncomfortable (14%), possible but painful (58%) or impossible due to pain (11%). Those who disclosed changes with orgasm (n=43, 31%) reported it was more difficult (26%), or impossible (23%). Of those completing the FSFI (n=108, 78%), median Desire Domain score was 1.8 (IQR 1.2), and median Total Score was 9.85 (IQR 13.3), with 97% of patients meeting criteria for FSD. Mean total FSFI score, as well as lubrication, orgasm, satisfaction, and pain domain scores were significantly lower in high AVES. Multivariate analyses revealed that women with poor FSFI satisfaction domain score (&amp;lt;3.6) was significantly more likely to have high AVES (aOR 2.81; 95%CI 1.03-7.65; p=0.044). Conclusions The present study characterizes the range of anatomic changes associated with sexual dysfunction in a diverse cohort of female cancer patients. Future work will describe treatment strategies employed and their effectiveness at symptom resolution and quality-of-life improvement to meet the needs of this growing population. Disclosure No

(135) Keratin Pearl Excision for Clitorodynia and Female Sexual Dysfunction

Abstract Introduction Clitoral adhesions occur when the clitoral prepuce adheres to the glans clitoris. This can cause accumulation of desquamated epithelial cells under the prepuce, resulting in the formation of smegmatic pseudocysts and keratin pearls. A keratin pearl is a focus of central keratinization within concentric layers of squamous cells. Presence of these firm, millimeter-sized masses can lead to clitoral irritation and hypersensitivity (similar to a grain of sand in the eye). Although keratin pearls have been described in the literature, there is little known about their clinical presentation or association with female sexual dysfunction (FSD). Objective Investigate the effectiveness of keratin pearl excision as a treatment for clitoral pain and female sexual dysfunction. Methods A retrospective chart review was conducted in two metropolitan gynecology clinics specializing in vulvar pain between January 2017 and December 2021. Patients presenting with clitoral pain (clitorodynia) were identified in the electronic medical record through a search of physician-entered diagnoses and confirmed via review of the clinical notes. Adult patients with documented clitoral pain as well as clitoral adhesions (clitoral phimosis) and keratin pearls noted on exam were included in the study. Female Sexual Dysfunction (FSD) was measured with the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R). Prospective data was collected via an electronic follow-up survey. Data were presented in means and percentages. Results Fifty-eight patients met inclusion criteria. Average age at presentation was 35 years (range 19-73 years). Self-reported ethnicity of the study population was 81% White, 7% Hispanic, 5% Asian, 2% Black, with no response from 5% of participants. Preliminary results show that patients reported a 66% decrease in mean clitoral discomfort (p &amp;lt; 0.0001) and a 52% reduction in mean difficulty with orgasm (p = 0.019) after excision of keratin pearls. Patients who completed the follow-up questionnaire (n = 18) had a mean FSFI total score of 18.3 compared to mean total baseline FSFI of 13.11 (p = 0.03). The mean FSFI score for pain was 2.85 at follow up compared to 1.52 at baseline (p = 0.01). The mean FSFI score for orgasm was 3.36 at follow up compared to 2.16 at baseline (p = 0.03). Although not statistically significant, most likely because of a small sample size, the mean FSFI score was higher at follow-up than at baseline for lubrication (45%), arousal (42%), satisfaction (19%), and desire (17%). Patients had no change in mean FSD-R score from baseline to follow up. Conclusions Clitorodynia associated with clitoral adhesions and keratin pearls occurs in women of all ages. Excising keratin pearls may reduce female sexual dysfunction. These preliminary results suggest that excising keratin pearls may improve clitoral discomfort and reduce difficulty with orgasm. Excising keratin pearls may also lead to an improvement in overall female sexual function. Disclosure No

Pelvic Recovery After Endometrial Cancer Treatment: Patient-Reported Outcomes and MRI Findings

Most women with endometrial cancer (EC) have an excellent prognosis and may be cured. However, treatment-related pelvic functional impacts may affect long-term quality of life. To better understand these concerns, we explored correlations between patient-reported outcomes and pelvic magnetic resonance imaging (MRI) features in women treated for EC. Women with histologic diagnosis of EC were consented preoperatively and completed the validated Female Sexual Function Index (FSFI) and Pelvic Floor Dysfunction Index (PFDI) questionnaires at preoperative, 6-week, and 6-month follow-up visits. Pelvic MRIs with dynamic pelvic floor sequences were performed at 6 weeks and 6 months. A total of 33 women participated in this prospective pilot study. Only 53.7% had been asked about sexual function by providers while 92.4% thought they should have been. Sexual function became more important to women over time. Baseline FSFI was low, declined at 6 weeks, and climbed above baseline at 6 months. Hyperintense vaginal wall signal on T2-weighted images(10.9 vs. 4.8, p=.002) and intact Kegel function (9.8 vs. 4.8, p=.03) were associated with higher FSFI. PFDI scores trended toward improved pelvic floor function over time. Pelvic adhesions on MRI were associated with better pelvic floor function (23.0 vs. 54.9, p=.003). Urethral hypermobility (48.4 vs. 21.7, p=.01), cystocele (65.6 vs. 24.8, p<.0001), and rectocele (58.8 vs. 18.8, p<.0001) predicted worse pelvic floor function. Use of pelvic MRI to quantify anatomic and tissue changes may facilitate risk stratification and response assessment for pelvic floor and sexual dysfunction. Patients articulated the need for attention to these outcomes during ECtreatment.

Clinical Presentation of Clitorodynia associated with Clitoral Adhesions and Keratin Pearls

ABSTRACT Introduction Clitoral adhesions occur when the clitoral prepuce adheres to the glans clitoris. This can lead to accumulation of desquamated epithelial cells under the prepuce, resulting in the formation of smegmatic pseudocysts and keratin pearls. A keratin pearl is a focus of central keratinization within concentric layers of squamous cells. Presence of these firm, millimeter-sized masses can lead to clitoral pain (similar to a grain of sand in the eye). Although keratin pearls have been described in the literature, there is little known about their clinical presentation or association with female sexual dysfunction (FSD). Objective Explore the clinical presentation of clitoral pain associated with clitoral adhesions and keratin pearls related to concomitant genitopelvic pain conditions and sexual dysfunction. Methods A retrospective chart review was conducted in two metropolitan gynecology clinics specializing in vulvar pain between January 2018 and September 2021. Patients presenting with clitoral pain (clitorodynia) were identified in the electronic medical record through a search of physician-entered diagnoses and confirmed by review of the clinical notes. Adult patients with documented clitoral pain as well as clitoral adhesions (clitoral phimosis) and keratin pearls noted on exam were included in the study. FSD was measured with the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R). Data was presented in means and percentages. Results Forty-one patients met inclusion criteria. Average age at presentation was 35 years (range 19-73 years). Self-reported ethnicity of the study population was 73% White, 5% Hispanic, 5% Asian, 2% Black, with no response from 15% of participants. Vulvar lichen sclerosus was noted in 17% (7/41) of patients, with an average age of 46 years (range 24-73 years). Seventy-six percent (31/41) of patients also had the diagnosis of overactive (hypertonic) pelvic floor muscle dysfunction (PFD), 25% (8/31) had pudendal neuralgia and 10% (3/31) had interstitial cystitis/painful bladder syndrome. Forty-six percent (19/41) of patients had provoked vestibulodynia (PVD) associated with a hormonal factor (hormonal contraceptive use, postpartum/breastfeeding, perimenopause, or menopause). Recurrent vulvar candidiasis or tinea cruris was noted in 5% of patients. Four patients (10%) presented with clitoral pain alone and were not found to have other identified genitopelvic pain conditions. Baseline FSFI and FSDS-R data were available in 35 patients. Mean FSFI score was 13.25, with 91% of patients meeting criteria for FSD (total FSFI score &amp;lt; 26.55). Mean scores for FSFI domains were: desire (2.4), arousal (2.1), lubrication (2.5), orgasm (2.0), satisfaction (2.5), and pain (1.6). Mean FSDS-R score was 29.42, with 89% of patients meeting criteria for FSD (FSDS-R score ³11). Conclusions Clitoral pain associated with clitoral adhesions and keratin pearls occurs in women of all ages. Clitoral adhesions are not confined to patients with vulvar lichen sclerosus. A vast majority of patients with clitoral adhesions and keratin pearls have additional chronic vulvar pain conditions, most commonly overactive PFD, pudendal neuralgia, or hormonally-associated PVD. Clitoral pain with clitoral adhesions and keratin pearls is associated with FSD and sexual distress. Clitorodynia and clitoral phimosis should be identified in the clinical evaluation of genitopelvic pain. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant for Good Clean Love and Mahana Therapeutics; part-time employee of Dare Bioscience. Received research funding from Dare Science, SST, Endoceutics, The Cellular Medicine Association, and Ipsen for other projects. He is a consultant for Ipsen, SST, and AMAG

More than just “vaginal dryness”: Addressing an unmet need for sexual health intervention in female cancer survivors.

e24050 Background: Female sexual dysfunction (FSD) in cancer survivors is underreported and therefore undertreated. This study aims to describe the population of female cancer survivors seeking treatment for sexual dysfunction through a novel sexual health after cancer program. Methods: We conducted a retrospective analysis to characterize patients presenting to the MUSIC (Menopause, Urogenital, Sexual Health and Intimacy Clinic) Program at a NCI-designated cancer center in South Florida. Patients received a baseline Female Sexual Function Index (FSFI) and underwent a physical, including abdominopelvic, exam. The FSFI is a 19-item survey previously validated for use in female cancer survivors. Severity of dysfunction (by presenting symptom, physical exam, and FSFI) was correlated to demographic and cancer characteristics. Sexual dysfunction was defined as ≤26.55. Results: Between 2020-2021, 104 female cis-gender women with a median age of 46 (range 19-75) at diagnosis were seen. 56% identified as Hispanic/Latinx. Most were treated for breast (80%) or gynecologic (10%) cancer. Common presenting symptoms included vaginal dryness (55%), painful sex (45%), low desire (36%) and hot flashes (22%). Patients who disclosed details about pain (n = 62) reported penetration was possible but uncomfortable (16%), possible but painful (66%) or impossible due to pain (18%). Those who disclosed changes with orgasm (n = 43) reported it was more difficult (26%), or impossible (23%). Of those completing the FSFI (n = 66), median Desire Domain score was 1.2 (IQR 1.2-2.4), and median Total Score was 8.1 (IQR 2.9-16.4), with 97% of patients meeting criteria for FSD (Table). Conclusions: The present study highlights a continued unmet need to address severe sexual health concerns in the growing female cancer survivor population. Future work will describe treatment strategies employed and their effectiveness at symptom resolution and quality-of-life improvement.[Table: see text]

The Effect of Cognitive Behavioral Therapy on Sexual Function in Infertile Women: A Randomized Controlled Clinical Trial

Infertility and its consequences can have effects on various aspects of a couple’s life and also in their marital relationships. This study aimed to investigate the effect of cognitive behavioral therapy (CBT) on sexual function in infertile women. The participants included 52 infertile women randomly assigned to intervention and control groups. A group-based, six-session sexual counseling using a CBT approach was also performed for the intervention group. Sexual functions of the participants in both groups were then assessed via the Female Sexual Function Index (FSFI) at three points in time. The findings revealed no statistically significant difference in the baseline FSFI mean scores of both groups. A significant difference was also reported for FSFI mean scores in the intervention group (29.35 ± 2.71) in comparison with those in the control group (25.84 ± 2.52) (p < 0.001) one month after intervention, with an effect size of 0.32. The mean scores of all the sexual-function domains, including sexual desire (p < 0.001), arousal (p < 0.001), lubrication (p < 0.001), orgasm (p < 0.001), satisfaction (p < 0.001), and pain (p < 0.001), among the participants in the intervention group had also significantly increased following CBT implementation. The results of this study could be used to promote sexual health in infertile women.

Effects of dehydroepiandrosterone (DHEA) supplementation on sexual function in premenopausal infertile women.

To investigate the effects of dehydroepiandrosterone (DHEA) supplementation on female sexual function in premenopausal infertile women of advanced ages. This observational study was conducted in an academically affiliated private fertility center. Patients included 87 premenopausal infertile women, 50 of whom completed the study including the Female Sexual Function Index (FSFI) questionnaires and comprehensive endocrine evaluation before and 4-8 weeks after initiating 25 mg of oral micronized DHEA TID. Age of patients was 41.1 ± 4.2 years, BMI 24.4 ± 6.1 kg/m2, 86% were married, and 42% were parous. Following supplementation with DHEA, all serum androgen levels increased (each P < 0.0001), while FSH levels decreased by 2.6 ± 4.4 from a baseline of 10.3 ± 5.4 mIU/mL (P = 0.009). The FSFI score for the whole study group increased by 7% (from 27.2 ± 6.9 to 29.2 ± 5.6; P = 0.0166). Domain scores for desire increased by 17% (P = 0.0004) and by 12% for arousal (P = 0.0122); lubrication demonstrated an 8% trend towards improvement (P = 0.0551), while no changes in domain scores for orgasm, satisfaction, or pain were observed. Women in the lowest starting FSFI score quartile (<25.7), experienced a 6.1 ± 8.0 (34%) increase in total FSFI score following DHEA supplementation. Among these women, improvements in domain categories were noted for desire (40%), arousal (46%), lubrication (33%), orgasm (54%), satisfaction (24%), and pain (25%). This uncontrolled observational study implies that supplementation with DHEA improves sexual function in older premenopausal women with low baseline FSFI scores.

Effect of Single-Session, Cryogen-Cooled Monopolar Radiofrequency Therapy on Sexual Function in Women with Vaginal Laxity: The VIVEVE I Trial.

Objective: This subanalysis of the VIVEVE I trial aimed to evaluate the impact of cryogen-cooled monopolar radiofrequency (CMRF) therapy, for the treatment of vaginal laxity, on the domains of sexual function included in the Female Sexual Function Index (FSFI).Materials and Methods: The VIVEVE I clinical trial was prospective, randomized, single-blind, and Sham-controlled. Nine clinical study centers in Canada, Italy, Spain, and Japan were included. This subanalysis included premenopausal women with self-reported vaginal laxity who had ≥1 term vaginal delivery and a baseline FSFI total score ≤26.5, indicating sexual dysfunction. Enrolled subjects were randomized (2:1) to receive CMRF therapy [Active (90 J/cm2) vs. Sham (≤1 J/cm2)] delivered to the vaginal tissue. Independent analyses were conducted for each FSFI domain to evaluate both the mean change, as well as the clinically important change for Active- versus Sham-treated subjects at 6 months post-intervention.Results: Subjects randomized to Active treatment (n = 73) had greater improvement than Sham subjects (n = 35) on all FSFI domains of sexual function at 6 months postintervention. The analysis of covariance change from baseline analyses showed statistically significant improvements, in favor of Active treatment, for sexual arousal (p = 0.004), lubrication (p = 0.04), and orgasm (p = 0.007). In addition, Active treatment was associated with clinically important and statistically significant improvements in sexual desire [Odds ratio (OR) = 3.01 (1.11–8.17)], arousal [OR = 2.73 (1.06–7.04)], and orgasm [OR = 2.58 (1.08–6.18)].Conclusions: This subanalysis showed CMRF therapy is associated with statistically significant and clinically important improvements in sexual function in women with vaginal laxity. These findings provide the first randomized, placebo-controlled energy-based device evidence for functional improvements associated with a nonsurgical modality for a highly prevalent and undertreated condition.

A Pilot Study of a Topical Intervention for Treatment of Female Sexual Dysfunction.

Many investigators reported that pharmacological treatment of female sexual dysfunction (FSD) has been a promising field yet to be explored. The purpose of this pilot study was to investigate the efficacy and safety of a topical cream containing small concentrations of three vasodilators with different mechanisms of action in treating FSD. In this randomized, controlled pilot trial, premenopausal (n = 30) and postmenopausal (n = 30) cases of 21- to 62-year age range with FSD were allocated randomly into 15 given placebo or 15 given active cream in each group. The women included had FSD for more than a 6-month duration and a total score of Female Sexual Distress Scale-Revised of at least 15. Assessing sexual function by measuring female sexual function index (FSFI) during five clinic visits, one at the end of baseline week and at the end of each week of the 4-week treatment period. The primary end point was changed from baseline FSFI total scores to week 4 treatment. Secondary end point included the changes from baseline arousal, desire, orgasm, and satisfaction scores to week 4 treatment. The sexual problem reported by patients was orgasmic or/and arousal disorders. In premenopausal cases, active cream led to a high significant increase in mean change FSFI total score from the baseline to week 4 compared with placebo (1.7 ± 1.886 vs 13.35 ± 4.646, respectively; P < 0.0001). Greater improvement of mean change of orgasm and arousal domain score was also observed (0.3 ± 0.45 and 0.35 ± 0.39 vs. 2.66 ± 0.63 and 1.87 ± 0.168, respectively; P < 0.0001). In postmenopausal cases, there were significantly greater improvements with active cream in all sexual functions compared with placebo cream (P < 0.0001). In triple cream, mean change of FSFI total score, orgasm domain score, and arousal score domain were 14.85 ± 6.33, 1.87 ± 0.168 and 2.66 ± 1.182, whereas in the placebo cream, they were 1.54 ± 2.1,0.7 ± 0.76 and 0.22 ± 0.44, respectively. Meanwhile, orgasm scores increased significantly after the use of placebo cream. No serious adverse effects were reported during treatment. The results of the pilot trial suggest that topical cream containing small concentrations of three vasodilators may act synergistically, and was effective in improving arousal, orgasmic, and satisfaction disorder with a safer profile for premenopausal and postmenopausal women with FSD. Further studies are recommended to be conducted using a large number of nondepressive and depressive patients.

Effectiveness of a low dose testosterone undecanoate to improve sexual function in postmenopausal women.

BackgroundAdding testosterone to hormonal therapy could improve sexual function and general well-being among women during climacteric. We evaluated the effectiveness of testosterone undecanoate on sexual function in postmenopausal women utilizing the standardized questionnaire FSFI score.MethodsPostmenopausal women with sexual complaints and Female Sexual Function Index (FSFI) ≤ 26.5 were enrolled in to this randomized, double-blinded, placebo-controlled trial. Participants were randomly assigned to 8-week treatment with either oral testosterone undecanoate 40 mg or placebo twice weekly with daily oral estrogen. The FSFI scores before and after treatment were compared to assess any improvement of sexual function.ResultsSeventy women were recruited of which each group had 35 participants. The baseline characteristics and baseline FSFI scores were comparable between both groups. After 8 weeks of treatment, the FSFI scores significantly improved in both groups when compared to the baseline but the FSFI scores from the testosterone group were significantly higher than in the placebo group post-treatment (28.6 ± 3.6, 25.3 ± 6.7, respectively, p = 0.04). There was no difference in adverse effect between the two groupsConclusionsThe twice weekly addition of testosterone undecanoate to daily oral estrogen was associated with a significant improvement in sexual function among postmenopausal women than the use of the estrogen alone.Trial registrationClinicalTrials.gov Identifier NCT01724658 (February 17, 2012).

Flibanserin: Approval of a controversial drug for a controversial disorder

Byline: T. Sathyanarayana Rao, Chittaranjan. Andrade Flibanserin (BIMT 17; Addyi; Sprout Pharmaceuticals, North Carolina, USA) is an agonist at postsynaptic (but not presynaptic) serotonin (5HT) 5HT1a receptors and an antagonist at 5HT2 receptors; the binding appears preferential for prefrontal cortex (PFC) pyramidal neurons that regulate monoamine release. Thus, flibanserin dosing results in increased release of dopamine (DA) and norepinephrine (NE) in the PFC. Flibanserin is also associated with decreased release of 5HT in the PFC, nucleus accumbens, and hypothalamus, but not hippocampus. Whereas DA and NE putatively increase sexual desire and arousal and 5HT inhibits sexual desire and arousal, this pharmacodynamic profile may explain the suggested benefits of the drug in women with hypoactive sexual desire disorder (HSDD). Weak and probably nonsignificant actions of flibanserin include antagonism at 5HT2b, 5HT2c, and D4 receptor sites.[sup][1],[2] Flibanserin was originally developed as an antidepressant [sup][3] with a potentially rapid onset of action;[sup][4] it was effective in some but not all animal models of depression.[sup][5] Phase 2 randomized controlled trials (RCTs) failed to find it effective against depression; however, interestingly, the drug outperformed placebo on responses to the question“how strong is your sex drive."[sup][3] On September 22, 2015, only 76 hits emerged in a PubMed search with the key word flibanserin, and only 9 hits emerged with the clinical trial search filter applied. The failed antidepressant data are unavailable in PubMed and presumably remain unpublished, but the sexual function findings have been released. Kennedy [sup][6] examined data from 4 RCTs of flibanserin (100–200 mg/day) in men ( n = 369) and women ( n = 523) with major depressive disorder. All RCTs had an active comparison treatment arm, and two RCTs were additionally placebo-controlled. Patients in the RCTs had been assessed using the Arizona Sexual Experiences Scale and the Hamilton Depression Rating Scale (HAM-D) genital symptoms item. In general, it appeared that flibanserin was associated with low or placebo-level risk of treatment-emergent sexual dysfunction. In one RCT, reported improvement in sexual functioning in women with baseline sexual dysfunction was 70% versus 30% for flibanserin versus placebo groups. In another RCT, flibanserin was associated with significantly greater improvement on the genital symptoms HAM-D item at weeks 4, 6, and 8. In the other RCTs, outcomes related to sexual functioning were inconsistent.[sup][6] Thus, there seemed to be a weak signal suggesting that flibanserin carries benefits for sexual functioning in women with depression. Four important RCTs and two long-term studies have now been published on the use of flibanserin for HSDD. HSDD is characterized by low sexual desire as a result of which the individual experiences distress or interpersonal difficulty. The condition is not diagnosed if the low desire is due to medications, substances of abuse, a co-existing medical or psychiatric condition, or relationship problems. HSDD is considered to be acquired when it arises in an individual who had normal sexual desire earlier; it is considered generalized when it is not specific to a type of sexual activity, a situation, or a partner.[sup][7] The four RCTs, with a somewhat sexist slant, were named after flowers: DAISY,[sup][8] VIOLET,[sup][9] BEGONIA,[sup][10] and SNOWDROP.[sup][11] All RCTs were 24 weeks studies, conducted in women with premenopausal HSDD. The mean age of the women was about 36 years, and the mean duration of HSDD was about 5 years. All women in these studies were generally healthy, and so the findings of safety and efficacy cannot be generalized to women with medical and neuropsychiatric conditions, especially those receiving psychotropic drugs. The major outcomes were assessed in the last 4 weeks of treatment relative to baseline. …

Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial.

To evaluate sexual function in midlife women taking low-dose oral estradiol or venlafaxine for hot flushes. In an 8-week randomized controlled trial among women aged 40-62 years, sexual function was compared between 0.5 mg oral estradiol per day or 75 mg venlafaxine per day (both compared with a placebo). Measures included composite and six domain scores from the Female Sexual Function Index and sexually related personal distress. Participants were aged 54.6 years (standard deviation [SD] 3.8) years, 59% white, with 8.1 (SD 5.3) daily hot flushes. Median composite baseline Female Sexual Function Index score was 16.3 (SD 11.9, n=256) for all women and 21.7 (SD 9.3, n=198) among sexually active women. Composite mean Female Sexual Function Index change from baseline to week 8 was 1.4 (95% confidence interval [CI] -0.4 to 3.2) for estradiol, 1.1 (95% CI -0.5 to 2.7) for venlafaxine, and -0.3 (95% CI -1.6 to 1.0) for placebo. Composite Female Sexual Function Index and sexually related distress change from baseline did not differ between estradiol and placebo (P=.38, P=.30) or venlafaxine and placebo (P=.79, P=.48). Among sexually active women, Female Sexual Function Index domain score change from baseline differences (active compared with placebo) in desire was 0.3 (95% CI 0.0-0.6) for estradiol, -0.6 (95% CI -1.2 to 0.0) in orgasm for venlafaxine, and 0.9 (95% CI 0.2-1.6) in penetration pain for venlafaxine. No women reported adverse events related to sexual dysfunction. Overall sexual function among nondepressed midlife women experiencing hot flushes did not change over 8 weeks with low-dose oral estradiol or venlafaxine (compared with placebo), although a subtle increase in desire (estradiol) and decreases in orgasm and pain (venlafaxine) may exist. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01418209. I.

Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study of the Effects of Vaginal Testosterone Therapy

IntroductionWomen with breast cancer have better cancer-related outcomes with the use of aromatase inhibitors (AIs), but the physiological suppression of estradiol can negatively affect sexual functioning because of unpleasant urogenital and vaginal symptoms. Local health care practitioners have observed that the benefits of vaginal testosterone in allaying these unpleasant symptoms in women with breast cancer are similar to the benefits of vaginal estrogen in women without breast cancer.AimThe aim of this study was to evaluate the effects of using a daily vaginal testosterone cream on the reported sexual health quality of life in women with breast cancer taking AI therapy.MethodsThirteen postmenopausal women with breast cancer on AI therapy and experiencing symptoms of sexual dysfunction were recruited from an oncology practice. The women were prescribed a 300 μg testosterone vaginal cream daily for 4 weeks. During the first study visit, a vaginal swab was obtained to rule out the presence of Candida species or Gardnerella vaginalis in participants. Women with positive vaginal swabs were treated prior to starting the vaginal testosterone therapy.Main Outcome Measure The Female Sexual Function Index (FSFI) survey, measuring female sexual health quality of life, was administered during the first study visit and at the final study visit, after completing testosterone therapy.ResultsTwelve patients completed 4 weeks of daily vaginal testosterone therapy. When compared with baseline FSFI scores, there was a statistically significant improvement for individual domain scores of desire (P = 0.000), arousal (P = 0.002), lubrication (P = 0.018), orgasm (P = 0.005), satisfaction (P = 0.001), and pain (P = 0.000). Total domain scores reflecting sexual health quality of life also improved when compared with baseline (P = 0.000).ConclusionsThe use of a compounded testosterone vaginal cream applied daily for 4 weeks improves reported sexual health quality of life in women with breast cancer taking AIs. Dahir M and Travers-Gustafson D. Breast cancer, aromatase inhibitor therapy, and sexual functioning: A pilot study of the effects of vaginal testosterone therapy. Sex Med 2014;2:8–15.

Changes in Sexual Functioning in Women After Neuromodulation for Voiding Dysfunction

Sacral neuromodulation is a well-established treatment for urinary and bowel disorders with potential use for other disorders such as sexual dysfunction. To evaluate changes in sexual functioning in women undergoing neuromodulation for voiding symptoms. Patients enrolled in our prospective, observational neuromodulation database study were evaluated. Data were collected from medical records, and patient-completed Female Sexual Function Index (FSFI) and Interstitial Cystitis Symptom-Problem Indices (ICSI-PI) at baseline, 3, 6, and 12 months post-implant. Patients rated overall change in sexual functioning on scaled global response assessments (GRA) at 3, 6, and 12 months post-implant. We grouped women by baseline FSFI scores: less (score<26) and more sexually functional (score≥26). Data were analyzed with Pearson's Chi-square or Fisher's Exact test and repeated measures. Changes in FSFI and ICSI-PI scores in women grouped by baseline FSFI score<26 and ≥26. Of 167 women evaluated, FSFI scores improved overall from preimplant (mean 13.5±8.5) to 12 months (N=72; mean 15.9±8.9, P=0.004). At baseline and each follow-up point, ICSI-PI scores were similar between groups and improved through time. For patients in the FSFI<26 group there was improvement from baseline to 12-month scores (N=63; 11.9±6.9 to 14.8±8.7; P=0.0006). Improved FSFI domains included desire, orgasm, satisfaction, and pain. Furthermore, of the 74 subjects in this group not sexually active at baseline, 10 became sexually active during follow-up. In the FSFI≥26 group there was slight but statistically significant decline in mean scores between baseline and 12 months (N=9; 27.4±1.1 to 24.5±3.4; P=0.0302); however one had become sexually inactive. A significant decrease was seen in the satisfaction domain. Many factors affect sexual functioning in women; however sexual function may improve along with urinary symptoms after neuromodulation.

Open‐Label Extension Study of Flibanserin in Women with Hypoactive Sexual Desire Disorder

Hypoactive Sexual Desire Disorder (HSDD) is a common form of Female Sexual Dysfunction characterized by low sexual desire that causes distress or interpersonal difficulty. This 52-week open-label extension study aimed to assess the safety and tolerability of flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A) antagonist, in women with HSDD. Women with HSDD who had completed a trial of flibanserin or flibanserin placebo received flexible-dose flibanserin (50 or 100 mg once daily at bedtime [qhs] or 25 or 50 mg twice daily [bid]) for 52 weeks. Primary end points were: proportions of women with somnolence, sedation, fatigue, dizziness, nausea, and vomiting (adverse events [AEs] known to be associated with flibanserin); discontinuations due to AEs; and serious AEs. Secondary end points included change from baseline in Female Sexual Distress Scale-Revised total and Item 13 scores and Female Sexual Function Index (FSFI) total and desire domain score scores. FSFI total scores were used to classify women into FSFI remitters (FSFI score >26.55, indicating no clinical sexual dysfunction) and FSFI non-remitters (FSFI score <26.55). Of the 1723 women who received flibanserin, 962 (55.8%) completed 12 months' treatment, and 883 women were exposed to flibanserin 100 mg qhs for ≥180 days. Somnolence, sedation, fatigue, dizziness, nausea, and vomiting were reported by 15.8, 1.6, 7.6, 6.9, 6.3, and 1.4% of participants, respectively. A total of 185 participants (10.7%) discontinued due to AEs. Serious AEs were reported by 1.2% of participants. At study end, 42% of baseline non-remitters had improved their FSFI score to remission level. The proportion of baseline FSFI remitters in remission rose from 83% at week 4 to a stable value of ∼90%. Flibanserin was well tolerated. Sexual function improved in women who were not FSFI remitters at baseline, and was maintained in those who were remitters at baseline.

Long-term quality of life and pelvic floor dysfunction after bariatric surgery

To evaluate effects of bariatric surgery on pelvic floor mediated quality of life in morbidly obese women. Prospective cohort study of 44 women undergoing bariatric surgery. Thirty-six women gave data at baseline and at mean follow-up of 3.15 years following bariatric surgery. Although urinary impact questionnaire scores improved (-34.92, P = .0020), colorectal-anal impact questionnaire and pelvic organ prolapse impact questionnaire scores did not improve despite significant weight loss. Baseline female sexual function index scores were low (17.70 ± 8.38) and did not improve with weight loss (16.91 ± 9.75, P = .5832). Pelvic organ prolapse/urinary incontinence sexual questionnaire scores did improve (35.78 ± 6.06 preoperatively vs 38.22 ± 6.03 postoperatively, P = .0193). Bariatric surgery is associated with significant improvement in the impact of urinary incontinence on quality of life. Sexual function was poor, and improved only on the pelvic organ prolapse/urinary incontinence sexual questionnaire that evaluated urinary incontinence.

Sexual Function in Nondepressed Women Using Escitalopram for Vasomotor Symptoms

To evaluate sexual function in midlife women using selective serotonin reuptake inhibitors for vasomotor symptoms. Selective serotonin reuptake inhibitors effectively treat vasomotor symptoms but adversely affect sexual function in depressed populations. Information on sexual function in nondepressed midlife women using selective serotonin reuptake inhibitors for vasomotor symptoms is lacking; any treatments that might impair function are of concern. This was a randomized controlled trial comparing 8 weeks of escitalopram with placebo in women ages 40-62 years with 28 or more bothersome vasomotor symptoms per week. Change in Female Sexual Function Index composite score (ranges from 2 [not sexually active, no desire] to 36) and six sexual domains (desire, arousal, lubrication, orgasm, satisfaction, pain) and the Female Sexual Distress Scale, and a single-question of sexually-related personal distress from the Female Sexual Distress Scale, were compared between groups. Among all women, median composite baseline Female Sexual Function Index score was 18.1 (interquartile range 2.4-26.5, n=200) and among sexually active women was 22.8 (interquartile range 17.4-27.0, n=75) in the escitalopram group and 23.6 (interquartile range 14.9-31.0, n=70) in the placebo group. Treatment with escitalopram did not affect composite Female Sexual Function Index score at follow-up compared with placebo (P=.18 all women; P=.47 sexually active at baseline). Composite mean Female Sexual Function Index change from baseline to week 8 was 0.1 (95% confidence interval [CI] -1.5 to 1.7) for escitalopram and 2.0 (95% CI 0.2-3.8) for placebo. The Female Sexual Distress Scale results did not differ between groups (P=.73) nor did adverse reports of sexual function. At week 8, among those women sexually active at baseline, there was a small difference between groups in Female Sexual Function Index domain mean score change in lubrication (P=.02) and a marginal nonsignificant difference in orgasm (P=.07). Escitalopram, when used in the treatment of vasomotor symptoms, did not worsen overall sexual function among nondepressed midlife women.