Total Female Sexual Function Index Research Articles

(024) A Randomized Trial on the Sexual Effectiveness and Impact on the Vaginal Microbiome of Reformulated Personal Water Lubricants with Lowered Osmolality and pH in Premenopausal and Postmenopausal Women

Abstract Introduction Vaginal dryness may be associated with postmenopausal women; however, it may also occur due to chronic medical conditions and as a direct side effect from medications. Personal lubricants can address sexual complaints and symptomatology associated with vaginal dryness, although clinically published data supporting their efficacy remains limited. Age-associated vaginal-physiological changes due to hypoestrogenic milieux include increased pH, decreased natural lubrication, reduced endothelial rugae and altered vaginal microbiome. While personal lubricants may alleviate symptoms, their definitive effects on the vaginal microbiome remain understudied and underappreciated. Objective This study examined reformulated water-based lubricants (lowered osmolalities and pH,) and their effect on female sexual function compared to their counterparts (higher osmolalities/increased pH). A secondary analysis examined if these reformulated lubricants influenced the vaginal microbiome of women from different age groups. Methods An open-label, parallel-design study was performed in heterosexual women in stable monogamous relationships, aged 18–65 years with mild-to-moderate vaginal dryness and dyspareunia. The study population (n=174) included an approximate 50:50 ratio of premenopausal to postmenopausal women. The randomization schedule was stratified by menopausal status. Subjects were randomized to use one of five water-based lubricants and instructed to use their lubricant during vaginal intercourse at least once a week over a 4-week period. The Female Sexual Function Index (FSFI) measured sexual functioning after 4 weeks of use as an indicator of lubricant performance. More than a 4-point increase in total FSFI is deemed clinically important. From the study-enrolled subjects, 50 females were randomized to one of five lubricant treatment groups for secondary microbiome analysis. To this end, four vaginal swabs per participant were sampled during pre- (“baseline”) and post- (“2 hours”, “24 hours” and “4 weeks”) lubricant application to assess bacterial diversity via 16S sequencing. Additionally, vaginal moisture and pH measurements were collected at baseline, 2 hours, and 24 hours post-lubricant application and correlated with microbiome diversity and richness using non-parametric tests and linear mixed models. Results An increase in FSFI total score of >4 points was found for all lubricants in the total population and for 4/5 lubricants in the premenopausal subgroup, as indicated by the mean differences to baseline. The number of subjects in sexual function (total FSFI >26.55) after treatment was significantly greater than the number in sexual function before treatment for both subgroups (premenopausal 19.3% to 78.4%; postmenopausal 22.3% to 75.3%; p<0.0001 for both). Lactobacillus species and Gardnerella vaginalis were the predominant taxa across all participants. Repeated lubricant applications did not alter the vaginal microbiome for up to 4 weeks post-product applications. Microbial diversity and relative abundance differed significantly between age groups but remained unaffected during product applications. Relative abundance of Lactobacilli spp. negatively correlated with vaginal pH while that of Gardnerella spp. showed a positive correlation with vaginal pH across all age groups. Conclusions These reformulated lubricants can be used not only to relieve symptomatology of vaginal dryness and dyspareunia, but to enhance overall sexual satisfaction regardless of menopausal status. These study lubricants demonstrated no significant impact on vaginal microbiome. Further studies with larger samples are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Reckitt Benckiser Health. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Reckitt Benckiser Health.

(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 (>3) corresponds to more severe exam disruptions. Mean FSFI total and domain scores were compared between AVES groups (0-3 vs. >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 (<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

(085) Topical Capsaicin for Provoked Vestibulodynia

Abstract Introduction Provoked vestibulodynia (PVD), occurs when pain is localized in the vulvar vestibule and triggered by any vestibular contact (sexual or otherwise). PVD is the most common form of vulvodynia and there is currently no approved treatment. Capsaicin cream is hypothesized to improve vestibular allodynia in patients with neuroproliferative PVD by binding to the vanilloid receptor (TRPV1) on the C- afferent nociceptors and thereby causing defunctionalization of the TRPV1. Although capsaicin has been utilized as a treatment for vulvodynia, very little is known about its effectiveness in improving vestibular pain and sexual function. Objective Investigate the therapeutic potential of capsaicin cream as treatment for PVD. Methods Patients who were prescribed 0.025% capsaicin compounded in VersaBase cream were identified in the electronic medical record through a search of physician-entered diagnoses and confirmed with a prescription list from a compounding pharmacy. Adult patients with documented vulvodynia were included. Female Sexual Dysfunction (FSD) was measured before and after treatment with the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R). Results Twenty-five patients responded to the follow-up questionnaire. Average age at presentation was 30 years (range 18-52 years). Self-reported ethnicity of the study population was 76% White, 4% Latina, 4% Asian, 4% Mixed, and 4% Middle Eastern, with no response from 8% of participants. After consistent daily usage, 80% of patients were able to tolerate capsaicin application for the full 20 minutes. Washing the cream off with cold water was helpful for tolerating capsaicin application for 72% of patients, and 8% of patients found applying a topical anesthetic such as lidocaine helpful. The median amount of time required to increase tolerance to the full 20 minutes was 1-2 weeks. On a VAS scale, the mean pain score while initially applying capsaicin was 8.96, and the median was 10. While 48% of patients found capsaicin improved their vulvar pain, 56% of patients would recommend capsaicin as a treatment for vulvar pain. The mean FSDS score was 35.96 at baseline compared to 25.09 at follow-up (p < 0.0001). On a VAS scale, the mean self-reported vulvar pain score was 8.2 at baseline compared to 5.35 when using capsaicin consistently (p < 0.0001). The mean FSFI pain domain score was 0.98 at follow-up compared to 2.45 at baseline (p = 0.005). While not statistically significant, the mean total FSFI score was 15.44 at baseline compared to 17.84 at follow-up. Conclusions Capsaicin cream is a promising treatment for PVD. Among patients who are able to tolerate consistent daily usage, capsaicin cream significantly decreases vulvar pain. Patients should be counseled that topical capsaicin is initially severely painful, even with the use of topical anesthetics such as lidocaine. Emotional distress and trauma were reported among patients who were not able to tolerate capsaicin application. However, patients who were able to tolerate capsaicin reported feeling “grateful” and “satisfied” with the treatment. Capsaicin cream should be considered for patients who have failed more conservative treatments and proper counseling regarding application should be reviewed. Disclosure No

(475) Comparison of Female Sexual Function Index in Premenopausal Women and Postmenopausal Women

Abstract Introduction Menopause is known to have a significant impact on mental health, women's quality of life, and sexuality. Objective The purpose of this study is to evaluate the impact of menopause on sexual function in women. The associations of sexual function with demographic and clinical variables were evaluated. Methods We performed a retrospective study comparing the relationship between female sexual function index and menopause in premenopausal women and postmenopausal women. Patients with a diagnosis of benign gynecologic disease who admitted for gynecological surgery at our institution from January 2009 to December 2012 were evaluated. Total 349 women were enrolled in this study and complete the Female Sexual Function Index (FSFI) questionnaires. Risk factors for female sexual function were examined using logistic regression models. Patients were separated into two groups: premenopausal women (group 1), postmenopausal woman (group 2). Women with prior gynecologic surgery were excluded. Continuous variables was compared using the two sample t-test, while non-continuous variables using the Chi-squared test. Results The mean age of the premenopausal women group was 41.7 years, and the average age of the postmenopausal women group was 58.8 years. There was no difference in parity, body weight, height, BMI, disease incidence, and smoking rate between the two groups. Comparing the female sexual function between the two groups, there was a significant relationship between menopause and female sexual function; Desires disorder (p value=0.00), Arousal disorder (p value=0.002), Lubrication disorder (p value=0.003), Orgasm disorder (p value=0.019), Satisfaction disorder (p value=0.002), Pain (p value=0.001), Total FSFI (Premenopausal women; 20.3/postmenopausal women; 15.3, p value=0.001). The result of the FSFI study between the two groups, the postmenopausal women group showed a significant decrease compared to the premenopausal women in all areas. Conclusions Female sexual dysfunction (FSD) is a complex disorder which has an impact on women regardless of their age and race, and related to a variety of biological, psychological, and social determinants. Sexuality impact quality of life through effects on the emotional and psychological health of a woman. Consequently, clinicians who take care of women appreciate when they may be vulnerable to sexual dysfunction. The menopausal transition, a time characterized by hormonal, physiologic, and social changes, is often associated with sexual dysfunction. As postmenopausal woman population is increasing, the further study will be needed in a larger subgroup of women with long-term follow up period. 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 < 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

(003) New Treatment Approach for Female Sexual Dysfunction by Transvaginal Shockwave Therapy (TVST)

Abstract Introduction Female Sexual Dysfunction (FSD) is a common condition of women especially following menopause. In recent years, energy-based devices (EBD), such as lasers and radio-frequencies, have been marketed for vaginal rejuvenation and FSD. Low-intensity shockwave therapy (LIST) has been introduced as a treatment for male erectile dysfunction and may hold promise for FSD. In women energy has to be delivered to the vaginal wall to manifest its tissue regenerative potential. In this pilot study, we evaluated a specially designed transvaginal probe, which is able to deliver shockwave energy to the vaginal wall and the external genitalia. Objective To evaluate the safety and therapeutic efficacy of LIST, when applied transvaginally for the treatment of FSD and incontinence. We call this approach transvaginal shockwave therapy (TVST). Methods The study was a single-arm, pilot study conducted between February-August 2021. Fifteen female patients aged 45-61 years (mean age: 52.7 years) were recruited and 78.6% of them were post-menopausal. All women presented with sexual dysfunction and 7 of them (46.7%) also reported urinary incontinence. Treatment was performed with the MoreNova system (Hikkonu Ltd., Israel), an electromagnetic low-intensity shockwave generator, using a novel transvaginal probe. Energy flow density was 0.09 mJoule/mm2 and intensity was gradually increased to the maximal tolerable level (1.6-1.8). Each session delivered 400 shockwaves to 6 predefined anatomical areas: the frontal vaginal wall (11 and 1 o' clock positions), the labia minora and majora (left, right). Patients underwent a total of 6 treatment sessions over the course of three weeks (2 per week). Statistical analysis was performed using student’s t-test (paired, one-tail, significance at p<0.05). Results Sexual dysfunction was assessed with the Female Sexual Function Index (FSFI) and incontinence with the ICIQ-UI Short-Form. Evaluations were performed at baseline and at 1 and 3 month post treatment. One patient aborted (for reasons unrelated to treatment) and was excluded from analysis. No patient complained of pain or discomfort during or after treatment and no side-effects were reported. Mean total FSFI score at baseline was 13.93, increased significantly to 22.66 at 1 month and slightly decreased to 20.88 at 3 months post treatment. All domains of the FSFI were significantly improved both at 1 and 3 month follow-ups compared to baseline. Percentage of patients achieving minimally clinically important differences (MCID) of the FSFI domains (Krychman et al, 2018) was also estimated. It was found that at 1 month follow-up more than 70% of patients achieved improvements exceeding the MCID in the pain, orgasm and lubrication FSFI domains. At 3 months, this significant improvement was sustained in the pain and orgasm domains. Mean ICIQ-UI was 3,53 at baseline and decreased to 3 at 3 months and 2.28 at 3 months post treatment. Conclusions There is a great need for new, effective and safe therapies for FSD. Quite often FSD is not reported by the patients and disregarded by physicians who are not involved in sexual medicine. Robust scientific evidence as to the efficacy of EBDs is also lacking. In our study, we found that TVST is safe and very well-tolerated by the patients. It improved FSD up to 3 months post treatment and this improvement was evident in all domains of the FSFI. There was also improvement in incontinence, as documented by the ICIQ-UI index. This observation surely warrants further investigation. Our data, although limited, underline the need for large scale, controlled studies ideally targeting different genito-urinary conditions. Disclosure Yes, this is sponsored by industry/sponsor: Direx Clarification Industry funding only - investigator initiated and executed study.

A Randomized Trial on the Effectiveness of Five Water-Based Personal Lubricants in Premenopausal and Postmenopausal Women [ID: 1376759

INTRODUCTION: Vaginal dryness is generally associated with postmenopausal women; however, it may occur at all ages. Personal lubricants can relieve discomfort associated with vaginal dryness, although clinical data supporting the efficacy of many lubricants are limited. METHODS: An open-label, parallel-design study was performed in heterosexual women in monogamous relationships, aged 18–65 years with mild-to-moderate vaginal dryness and dyspareunia. The study population (n=174) included an approximate 50:50 ratio of premenopausal to postmenopausal women. The randomization schedule was stratified by menopausal status. Participants were randomized to use one of five water-based lubricants and instructed to use their lubricant during vaginal intercourse at least once a week over a 4-week period. The Female Sexual Function Index (FSFI) measured sexual functioning after 4 weeks of use as an indicator of lubricant performance. The total FSFI comprises six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain reduction. A greater than 4-point increase in total FSFI is considered clinically important. RESULTS: An increase in FSFI total score of greater than 4 points was found for all lubricants in the total population and for four of five lubricants in the premenopausal subgroup, as indicated by the mean differences to baseline. The number of participants in sexual function (total FSFI >26.55) after treatment was significantly greater than the number in sexual function before treatment for both subgroups (premenopausal, 19.3–78.4%; postmenopausal, 22.3–75.3%; P<.0001 for both). CONCLUSION: These lubricants can be used not only to relieve symptomatology of vaginal dryness and dyspareunia, but to enhance overall sexual satisfaction regardless of menopausal status.

Sexual Function in Pregnancy in a Nigerian Population: A Prospective Longitudinal Study.

Studies are abound from low- and middle-income countries (LMICs) on postpartum sexual dysfunction but very limited in pregnancy. The data will help clinicians in providing women with evidence-based information and counseling in these regards. To determine the effects of different trimesters of pregnancy on sexual functions and the possible risk factors for sexual dysfunction in pregnancy. The study was longitudinal in design, and study population consisted of 270 pregnant women attending antenatal care at the two largest tertiary hospitals in Enugu, Nigeria. The recruitment was in the first trimester, and each recruited participant served as her own control. Interviews were conducted at specific times in the three trimesters, and data regarding sexual functions were obtained using validated questionnaires. Analysis of variance (ANOVA) was performed to compare the mean total and domain female sexual function index (FSFI) scores between the three trimesters, and Bonferroni's test for significant association between any two trimesters as may be applicable. The risk factors were determined via multivariate logistic regression analysis. A P value ≤0.05 was considered statistically significant. The FSFI means total score decreased as pregnancy advanced. It was significantly lower in second trimester (T2) than in first trimester (T1) (P < 0.001), and significantly lower in third trimester (T3) than T1 (P < 0.001), but no difference between T3 and T2 (P = 0.759). Similarly, the mean frequency of coitus per week declined across the trimesters; lower in T2 than T1 (2.2 ± 0.7 vs. 2.4 ± 0.6; P < 0.01), and lower in T3 than T1, but no difference between T3 and T2. The overall rate of sexual dysfunction was 50.7% and the risk factors age ≥35 years (AdjOR: 1.4; 95%CI: 1.1-1.9; P: 0.01), multiparity (AdjOR: 1.7; 95%CI: 1.2-2.5; P: 0.013) and a previous history of cesarean section (AdjOR: 2.1; 95%CI: 1.7-2.6; P: 0.004). Sexual function declines as pregnancy advances and the rate of sexual dysfunction is high in Enugu, Nigeria. Obstetricians are encouraged to discuss sexual health issues during antenatal care services and make more efforts towards reducing the modifying obstetric risk factors.

Relationship between female sexual function, vaginal volume, vaginal resting tone, and pelvic floor muscle strength in women with stress urinary incontinence.

Vaginal morphology and pelvic floor muscle (PFM) strength may influence sexual stimulation, sensation, and orgasmic response. This study aimed to determine the relationship between female sexual function and PFM strength and vaginal morphology (represented by vaginal resting tone and vaginal volume) in women with stress urinary incontinence (SUI). Forty-two subjects with SUI were recruited for the study. Female sexual function was measured using the female sexual function index (FSFI) questionnaire. PFM strength was measured by digital palpation. Vaginal resting tone (mmHg) and vaginal volume (mL) were measured using a perineometer. The significance of the correlations between female sexual function and PFM function and hip muscle strength was assessed using Pearson's correlation coefficients. If a significant correlation between vaginal morphology and FSFI score was confirmed using Pearson's correlation, the cutoff value was confirmed through a decision tree. PFM strength was significantly correlated with desire (r=0.397), arousal (r=0.388), satisfaction (r=0.326), and total (r=0.315) FSFI scores. Vaginal resting tone (r=-0.432) and vaginal volume (r=0.332) were significantly correlated with the FSFI pain score. The cutoff point of vaginal resting tone for the presence of pain-related sexual dysfunction was >15.2 mmHg. PFM strength training should be the first strategy to improve female sexual function. Additionally, because of the relationship between vaginal morphology and pain-related sexual dysfunction, surgical procedures to achieve vaginal rejuvenation should be carefully considered.

Validation of the adapted female sexual function index among Chinese cisgender heterosexual women and sexual and gender minority women.

The Female Sexual Function Index (FSFI) remains the most widely used scale for assessing female sexual function. However, while an adapted version of the FSFI has been proven to be suitable for Western sexual minority women, it has yet to be used in China. This study aimed to validate the Mandarin Chinese version of the adapted FSFI among Chinese cisgender heterosexual women and sexual and gender minority women, and evaluate its psychometric properties. A cross-sectional online survey was conducted. The modified scoring method related to zero responses was examined, and structural validity, internal consistency, internal reliability, convergent validity, and known-group validity were evaluated. The primary measure was the adapted FSFI, and the Positive Sexuality Scale and the New Sexual Satisfaction Scale-Short Form were used to test convergent validity. A total of 431 Chinese adult women were recruited, including 193 cisgender heterosexual women and 238 sexual and gender minority women. Confirmatory factor analysis using the original scores supported the original 6-factor model. Using both Cronbach's α and McDonald's ω, the results showed that the values of the total scale and 6 subscales were in the 0.76 to 0.98 and 0.83 to 0.98 ranges, respectively, indicating satisfactory reliability. Moderate-to-strong correlations among the total FSFI scores and positive sexuality and sexual satisfaction were found (r = 0.32-0.71), supporting good convergent validity. The adapted FSFI facilitates the use of more inclusive language in the clinical setting, allowing for a more comprehensive and unbiased assessment of sexual function in all women. This study recruited both cisgender women of varied sexual orientations and gender minorities who were assigned female at birth, demonstrating that the adapted FSFI could be suitably applied to sexual minority populations. However, from a fully inclusive perspective of sex and gender, there is no research on how to accurately evaluate transgender women with female external genitalia or appropriately assess those with a female reproductive system but who do not self-identify as female. Therefore, more in-depth research is needed to further revise the FSFI for better use in the wider female population. This Chinese version of the adapted FSFI has good psychometric properties and is a reliable and valid instrument to assess female sexual function. Furthermore, the modified scoring method could be an effective alternative among samples of sexually inactive women.

Effect of epidural spinal cord stimulation on female sexual function after spinal cord injury.

Sexual dysfunction is a common consequence for women with spinal cord injury (SCI); however, current treatments are ineffective, especially in the under-prioritized population of women with SCI. This case-series, a secondary analysis of the Epidural Stimulation After Neurologic Damage (E-STAND) clinical trial aimed to investigate the effect of epidural spinal cord stimulation (ESCS) on sexual function and distress in women with SCI. Three females, with chronic, thoracic, sensorimotor complete SCI received daily (24 h/day) tonic ESCS for 13 months. Questionnaires, including the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS) were collected monthly. There was a 3.2-point (13.2%) mean increase in total FSFI from baseline (24.5 ± 4.1) to post-intervention (27.8 ± 6.6), with a 4.8-50% improvement in the sub-domains of desire, arousal, orgasm and satisfaction. Sexual distress was reduced by 55%, with a mean decrease of 12 points (55.4%) from baseline (21.7 ± 17.2) to post-intervention (9.7 ± 10.8). There was a clinically meaningful change of 14 points in the International Standards for Neurological Classification of Spinal Cord Injury total sensory score from baseline (102 ± 10.5) to post-intervention (116 ± 17.4), without aggravating dyspareunia. ESCS is a promising treatment for sexual dysfunction and distress in women with severe SCI. Developing therapeutic interventions for sexual function is one of the most meaningful recovery targets for people with SCI. Additional large-scale investigations are needed to understand the long-term safety and feasibility of ESCS as a viable therapy for sexual dysfunction. Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT03026816, NCT03026816.

Coping strategies, illness perceptions, and relationship dynamics contribute to female sexual function and sexual distress in Sjögren's syndrome.

Sexual dysfunction and sexual distress are common complaints for women with the autoimmune rheumatic disease Sjögren's syndrome (SS); however, the role of psychosocial and interpersonal factors has not previously been explored in SS. This study investigated whether psychosocial variables, such as coping strategies, illness perceptions, and relationship dynamics, contributed to sexual function and sexual distress for women with SS. Participants with SS completed an online cross-sectional survey that included prevalidated questionnaires assessing sexual function, sexual distress, disease-related symptom experiences, cognitive coping strategies, illness perceptions, relationship satisfaction, and partners' behavioral responses. Multiple linear regression was used to identify factors significantly associated with sexual function (total Female Sexual Function Index [FSFI] score) and sexual distress (total Female Sexual Distress Scale score) for women with SS. Study outcome measures were the FSFI, Female Sexual Distress Scale, EULAR Sjӧgren's Syndrome Patient Reported Index, numeric rating scale for vaginal dryness (0-10), Profile of Fatigue and Discomfort, Cognitive Emotion Regulation Questionnaire (CERQ), Brief Illness Perceptions Questionnaire (B-IPQ), West Haven-Yale Multidimensional Pain Inventory (WHYMPI), and Maudsley Marital Questionnaire. A total of 98 cisgender women with SS participated in the study (meanage = 48.13 years, SD = 13.26). Vaginal dryness was reported by 92.9% of participants, and clinical levels of sexual dysfunction (total FSFI score <26.55) were observed in 85.2% (n = 69/81) of cases. More vaginal dryness, lower CERQ positive reappraisal, and higher CERQ catastrophizing were significantly associated with poorer self-rated sexual function (R2 = 0.420, F3,72 = 17.394, P < .001). Higher CERQ rumination, lower CERQ perspective, lower WHYMPI distracting responses, and higher B-IPQ identity were significantly associated with higher sexual distress (R2 = 0.631, F5,83 = 28.376, P < .001). This study suggests that interpersonal and psychosocial factors are important contributors to sexual function and distress in women with SS and that the development of psychosocial interventions for this population is warranted. This study is one of the first to explore the impacts of coping strategies, illness perceptions, and relationship dynamics on sexual function and sexual distress for women with SS. Limitations of our study include its cross-sectional nature and narrow sample demographic, which limit the generalizability of our results to other population groups. Women with SS who utilized adaptive coping strategies had better sexual function and lower levels of sexual distress than women who utilized maladaptive coping strategies.

MP45-08 A SYSTEMATIC REVIEW AND META-ANALYSIS OF THE EFFECT OF MIRABEGRON ON THE SEXUAL HEALTH OF PATIENTS WITH OVERACTIVE BLADDER (OAB) AND SEXUAL DYSFUNCTION

You have accessJournal of UrologyCME1 Apr 2023MP45-08 A SYSTEMATIC REVIEW AND META-ANALYSIS OF THE EFFECT OF MIRABEGRON ON THE SEXUAL HEALTH OF PATIENTS WITH OVERACTIVE BLADDER (OAB) AND SEXUAL DYSFUNCTION Vasileios Sakalis, Michael Samarinas, Konstantinos Giannitsas, Ioannis Gkialas, Nikolaos Mertziotis, Charalampos Thomas, and Apostolos Apostolidis Vasileios SakalisVasileios Sakalis More articles by this author , Michael SamarinasMichael Samarinas More articles by this author , Konstantinos GiannitsasKonstantinos Giannitsas More articles by this author , Ioannis GkialasIoannis Gkialas More articles by this author , Nikolaos MertziotisNikolaos Mertziotis More articles by this author , Charalampos ThomasCharalampos Thomas More articles by this author , and Apostolos ApostolidisApostolos Apostolidis More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003291.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Published data support an effect of mirabegron on the sexual function of OAB patients further to its well-known effect on the bladder. This effect may be via activation of β3-adrenergic receptors in the corpus cavernosum tissue, causing vasodilatation independently of the NO-cGMP pathway. Other mechanisms involve a protective effect of mirabegron on pelvic endothelial dysfunction and induced vasorelaxation in both sexes’ genitalia. We systematically reviewed the literature concerning the effect of mirabegron on sexual dysfunction (SD) in both men and women. METHODS: A systematic search was performed in Embase, Medline, Cochrane and Clinical Trial databases up to September 2022. We included observational and comparative studies with primary outcome the post-treatment changes of sexual function in men or women with OAB and SD. We followed the PRISMA guidelines and Cochrane methodology. Risk of bias and confounding assessments were performed. The magnitude effect was expressed as Standard Mean Difference (SMD). RESULTS: Of 28 publications and conference abstracts selected for full-text screening, only six trials involving 259 patients (187 women and 72 men) met the inclusion criteria. None was randomized. The primary endpoint in women’s trials was the post-treatment changes in total FSFI (Female Sexual Function Index) score at 12 weeks. Meta-analysis showed a large-size treatment effect, with total FSFI score improving significantly from baseline [SMD]: -0.99 (95%CI:-1.43,-0.54, p<0.001) (Figure). Men’s trials assessed the post-treatment changes in IIEF-5 (International Index of Erectile Function) at 12 weeks. Meta-analysis showed a small-size but significant treatment effect [SMD]:-0.38 (95%CI:-0.74, -0.02, p=0.04). A phase II trial reported significant improvements in Sexual Health Inventory for Men scores at weeks 4 and 8 (p=0.0003) but not week 12. CONCLUSIONS: Current data support a significant beneficial effect of mirabegron in women suffering from SD and OAB and a smaller effect on the erectile function of men with OAB. The poor quality of included studies and the lack of randomized trials minimizes the value of these results. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e624 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Vasileios Sakalis More articles by this author Michael Samarinas More articles by this author Konstantinos Giannitsas More articles by this author Ioannis Gkialas More articles by this author Nikolaos Mertziotis More articles by this author Charalampos Thomas More articles by this author Apostolos Apostolidis More articles by this author Expand All Advertisement PDF downloadLoading ...

PD14-12 SEXUAL FUNCTION IN WOMEN FOLLOWING TENSION-FREE VAGINAL TAPE-OBTURATOR PROCEDURE: A PROSPECTIVE STUDY

You have accessJournal of UrologyCME1 Apr 2023PD14-12 SEXUAL FUNCTION IN WOMEN FOLLOWING TENSION-FREE VAGINAL TAPE-OBTURATOR PROCEDURE: A PROSPECTIVE STUDY Aymen Sakly, Walid Zakhama, Nejm Jleli, Aymen Mnasser, and Yassine Binous Aymen SaklyAymen Sakly More articles by this author , Walid ZakhamaWalid Zakhama More articles by this author , Nejm JleliNejm Jleli More articles by this author , Aymen MnasserAymen Mnasser More articles by this author , and Yassine BinousYassine Binous More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003261.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Midurethral tapes have shown favorable clinical outcomes for treating stress urinary incontinence (SUI). In the last decade, tension-free vaginal tape-obturator (TVT-O) lead to less complications with comparable results to conventional open surgeries and retropubic sling procedure. However, the effects of TVT-O on women’s sexual function are unclear. The aim of this study was to assess sexual function among women who underwent TVT-O for SUI. METHODS: From February 2018 to January 2022, we have enrolled a prospective study in which we recruited 63 women scheduled for correction of SUI by TVT-O procedure. Exclusion criteria were women without sexual activity, previous surgery for urinary incontinence or concomitant surgery for urogenital prolapse. Participants were required to complete the Female Sexual Function Index (FSFI) questionnaire. Preoperative and postoperative results were evaluated. Female sexual dysfunction was defined for a cutoff FSFI<26,55. The paired T-Student test was used to compare the scores. The significance level of p was set at 0,05. RESULTS: The mean age of our population was 64,4 years. Before surgery, the mean total FSFI score was 23.48±5.74. A female sexual dysfunction was observed in 68.2% of patients. The lowest score was attributed to desire, orgasm, and arousal items. Only 17 women (26,98%) have concomitant coital incontinence. Postoperatively, the mean resumption of sexual intercourses was at 2.7 months. The mean total FSFI score significantly increased to 28.617±5.21 (p<0.05). We found a significant improvement related to desire, satisfaction, and pain domains (p=0.03, p=0.01, p<0.001). In patients who had concomitant coital incontinence before surgery, the FSFI scores was higher than patients who did not have coital incontinence (1.67±1.84 vs. -0.13±2.15, p<0.05). CONCLUSIONS: TVT-O procedure provides significant improvement in the sexual lives of women. However, the patients who suffer from concomitant coital incontinence before the surgery will have a better sexual function improvement. Source of Funding: No funding © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e417 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Aymen Sakly More articles by this author Walid Zakhama More articles by this author Nejm Jleli More articles by this author Aymen Mnasser More articles by this author Yassine Binous More articles by this author Expand All Advertisement PDF downloadLoading ...

Better renal replacement therapy to improve sexual function in female patients with end-stage renal disease: A cross-sectional study.

Sexual dysfunction is commonly observed in patients with end-stage renal disease (ESRD). Sexual dysfunction in correlation with ESRD is associated with physiological and psychological problems resulting in low sexual desire, arousal, difficulties in achieving orgasm, and pain during intercourse. Studies on female sexual dysfunction (FSD) in correlation with renal replacement therapy are limited, and previous studies reporting contradictive results have indicated that the best modality for providing better outcomes (especially on FSD) remains unclear. Thus, this study aimed to compare the sexual function between female patients with ESRD who were on continuous ambulatory peritoneal dialysis (CAPD) and those on hemodialysis (HD). This study enrolled female patients who were randomly selected from the urology and renal division of the Internal Medicine Outpatient Clinic of our hospital from January 2020 to August 2021 and divided into the following groups: predialysis, HD, CAPD, and control groups. The participants were asked to fill out the Female Sexual Function Index (FSFI) questionnaires, and their data were recorded and analyzed using GraphPad Prism 9.0.0. Of the 280 patients, 200 female patients were included in this study. The rate of FSD (cutoff: 26.55) was 42% in the control group, 72% in the predialysis group, 62% in the CAPD group, and 66% the in HD group. The control group had a higher mean score in all parameters (p < 0.05). The total FSFI mean score indicated no significant difference (p > 0.05) between the patients on HD and those on CAPD; the mean of each point was almost identical except for satisfaction, which was higher among patients on CAPD (p < 0.05). Significant differences in the components of desire, arousal, orgasm, and satisfaction were observed between the groups. Patients on CAPD had better FSFI scores than the female patients with ESRD who were on HD, and the scores of both groups of patients were better than those of the predialysis group.

The efficacy and safety of temperature controlled dual-mode radiofrequency in women with vaginal laxity

ObjectiveVaginal laxity could negatively influence women’s sexual function. This study aimed to explore the efficacy and safety of temperature controlled dual-mode (monopolar and bipolar) radiofrequency (RF) in women with vaginal laxity.MethodsA total of 102 patients with vaginal laxity were treated with temperature-controlled RF. The present study implemented Vaginal Laxity Questionnaire (VLQ), Female Sexual Function Index (FSFI) questionnaire and Sexual Satisfaction Questionnaire (SSQ) on all patients at baseline and after treatment. Pelvic Organ Prolapse Quantification System (POP-Q) system was applied to physical examination, and vaginal manometer to examine the strength of voluntary contractions of the pelvic floor muscles.ResultsThe VLQ score was gradually increased after RF treatment at 1, 3, 6 and 12 months, accompanying by the significant improvement in total FSFI scores and the six domains (sexual desire, sexual arousal, lubrication, orgasm, satisfaction, pain). The increased sexual satisfaction based on the SSQ score was found after temperature-controlled RF. The result of POP-Q stage showed significant difference in women after treatment, with the women having Stage I of 45.10% at baseline, 36.27% at 1 month, 28.43% at 3 months, 19.61% at 6 months and 10.78% at 12 months. The mean pressure and mean duration of pelvic contractions were increased gradually at the 1-, 3-, 6- and 12- month follow-up.ConclusionTemperature controlled dual-mode (monopolar and bipolar) radiofrequency may be associated with improvement of vaginal laxity, and contribute to enhancement to female sexual function and pelvic floor muscles.

Autologous Fat Grafting in Female Genital Area Improves Sexual Function by Increasing Collagenesis, Angiogenesis, and Estrogen Receptors.

Vulvovaginal laxity, atrophic vaginitis, and orgasmic dysfunction are not only aesthetic but also sexual problems. Autologous fat grafting (AFG) facilitates tissue rejuvenation through the effects of adipose-derived stem cells; the fat grafts serve as soft-tissue filler. However, few studies have reported the clinical outcomes of patients undergoing vulvovaginal AFG. The aim of this study was to describe a new technique, micro-autologous fat transplantation (MAFT), for AFG in the vulvovaginal area. Posttreatment histologic changes in the vaginal canal that imply improved sexual function were assessed. This retrospective study enrolled females who underwent vulvovaginal AFG performed through MAFT between June 2017 and 2020. Assessments were based on the Female Sexual Function Index (FSFI) questionnaire and on histologic and immunohistochemical staining. In total, 20 female patients (mean age, 38.1 years) were included. On average, 21.9 mL of fat was injected into the vagina and 20.8 mL in the vulva and mons pubis area. Six months afterwards, the patients' mean total FSFI score (68.6) was significantly higher than that at baseline (43.8; P < .001). Histologic and immunohistochemical staining of vaginal tissues revealed substantially increased levels of neocollagenesis, neoangiogenesis, and estrogen receptors. By contrast, the level of protein gene product 9.5, which is associated with neuropathic pain, was considerably lower after AFG. AFG performed through MAFT in the vulvovaginal area may help manage sexual function-related problems in females. In addition, this technique improves aesthetics, restores tissue volume, alleviates dyspareunia with lubrication, and reduces scar tissue pain.

The Impact of HPV Diagnosis and Abnormal Cervical Cytology Results on Sexual Dysfunction and Anxiety.

The objective of this study is to evaluate the effect of HPV diagnosis on the sexual function and anxiety levels of Turkish women. A total of 274 female patients who tested positive with HPV were included in the study and categorized into four groups: Group 1 (HPV 16/18 with normal cytology), Group 2 (HPV 16/18 with abnormal cytology), Group 3 (other high-strain HPV with normal cytology), and Group 4 (other high-strain HPV with abnormal cytology). All patients filled out the Beck Anxiety Inventory (BAI) and Female Sexual Function Index (FSFI) at the time when they tested positive for HPV and during the two-month and six-month follow-ups. Significant increases were observed in BAI scores in all four groups, whereas significant decreases were observed in total FSFI scores in Groups 1 and 2 only(p < 0.05). BAI scores of Groups 1 and 2 were significantly higher than those of Groups 3 and 4 (p < 0.05). FSFI scores of Groups 1 and 2 measured during the sixth-month follow-up were significantly decreased (p = 0.004 and p < 0.001, respectively). Our findings suggest that patients with HPV 16 and 18 positivity and abnormal cytological findings are more likely to have high anxiety and sexual dysfunction.

Sexual function remains persistently low in women after treatment for colorectal cancer and anal squamous cell carcinoma.

Women diagnosed with colorectal cancer (CRC) or anal squamous cell carcinoma (ASCC) are at high risk of sexual dysfunction after treatment, yet little is known about recovery and risk factors for chronic dysfunction. We aimed to describe sexual function and sexual activity among women who underwent definitive treatment for CRC or ASCC, examine relationships between time since treatment completion and sexual function, and explore factors associated with desire and changes in sexual desire over time. As part of a prospective cohort study of patients with gastrointestinal cancer at the University of California San Francisco, female-identifying participants who finished definitive treatment for CRC or ASCC completed the Female Sexual Function Index (FSFI) at 6- to 12-month intervals. We used multivariable linear mixed models to explore factors associated with the FSFI desire subscale. Outcomes were rates of sexual activity, proportion at risk for sexual dysfunction (FSFI score <26.55), total FSFI score, and FSFI desire subscale. Among the 97 cancer survivors who completed at least 1 FSFI, the median age was 59years, the median time since treatment end was 14months, and 87% were menopausal. Fifty-five women (57%) had a history of colon cancer; 21 (22%), rectal cancer; and 21 (22%), ASCC. An additional 13 (13%) had a current ostomy. Approximately half the women were sexually active (n = 48, 49%). Among these 48 sexually active women, 34 (71%) had FSFI scores indicating risk for sexual dysfunction. Among the 10 sexually active women who completed a FSFI ≥2years since end of treatment, the median total score was 22.6 (IQR, 15.6-27.3). None of the evaluated characteristics were associated with desire (age, tumor site, treatment, menopause status, or ostomy status). Consistent with prior studies, we found low desire scores after treatment for CRC or ASCC, with little recovery over time, suggesting that patients should not expect an eventual rebound of sexual function. Strengths of our study include longitudinal data and use of the validated FSFI. Women with ASCC composed 22% of our cohort, allowing for insight into this rare disease group. Limitations of this study include the small sample size, particularly for longitudinal analyses, and the enrollment of patients at variable times since treatment end. We observed a high prevalence of sexual health concerns, including low desire, after the treatment of CRC and ASCC that persisted for years after treatment was completed.

A randomized trial on the effectiveness and safety of 5 water-based personal lubricants.

A range of personal lubricants with different formulations and subsequent properties are available for relief of discomfort associated with vaginal dryness; however, there are limited clinical data to support the efficacy and safety of many commercially available lubricants. To determine the effectiveness and safety of 5 water-based personal lubricants for the relief of intimate discomfort associated with vaginal dryness in pre- and postmenopausal women: 4 that were formulated to meet the World Health Organization (WHO) guidelines for osmolality and pH and 1 preexisting lubricant of higher osmolality and pH. An open-label, parallel-design study was performed in women aged 18 to 65years with mild-to-moderate vaginal dryness and dyspareunia. Participants were randomized to 1 of 5 lubricants (A-E) from 3 brands (Durex, KY, Queen V). They were instructed to use their allocated lubricants during vaginal intercourse at least once a week over a 4-week period. The Female Sexual Function Index (FSFI) measured sexual functioning after 4weeks of use as an indicator of lubricant performance. The primary outcome was change from baseline in total FSFI score after 4weeks of product use. A total of 174 women completed the study. The primary end point-a prespecified increase in FSFI ≥4 points from baseline after 4weeks of use-was met by all 5 lubricants tested. A statistically significant improvement was observed across all 6 domains of the FSFI from baseline to 4weeks of use with all 5 lubricants (P < .0001 for lubrication and pain reduction and P < .05 for all other domains). No serious adverse events occurred in the study, and the tolerance of all 5 lubricants was good/very good. The efficacy and safety of the tested lubricants are not compromised when formulated to meet the WHO criterion of osmolality ≤1200mOsm/kg. The lubricants tested in this investigation can be used not only to relieve symptomatology of vaginal dryness and dyspareunia but also to enhance overall sexual satisfaction. This study provides clinical evidence for the efficacy and safety of 5 lubricants, including those formulated to meet WHO guidelines, in relieving symptoms of vaginal dryness and improving the overall sexual experience. The open-label design may have introduced bias into the study. All 5 lubricants, including those formulated to be compliant with guidelines on pH and osmolality, can be considered effective and well tolerated for the relief of discomfort associated with vaginal dryness.