Assessing vaginal wall thickness by transvaginal ultrasound in breast cancer survivors: A pilot study.

AIM: There is need for a straightforward objective measure to evaluate vaginal wall changes related to hypoestrogenism. The aim of this pilot study was to evaluate a transvaginal ultrasound procedure for the quantification of vaginal wall thickness in order to differentiate between healthy premenopausal women and postmenopausal women with genitourinary syndrome of menopause using ultra-low-level estrogen status as a model. METHODS: We performed a prospective, two-arm, cross-sectional pilot study comparing vaginal wall thickness measured by transvaginal ultrasound in postmenopausal breast cancer survivors using aromatase inhibitors with genitourinary syndrome of menopause (GSM group) and healthy premenopausal women (control or C group) from October 2020 to March 2022. After intravaginal introduction of 20 cm3 of sonographic gel, vaginal wall thickness was measured by transvaginal ultrasound in the anterior, posterior, and right and left lateral walls (four quadrants). The study methods followed the STROBE checklist. RESULTS: According to the results of a two-sided t-test, the mean vaginal wall thickness of the four quadrants in the GSM group was significantly less than that of the C group (2.25 mm vs 4.17 mm, respectively; p < 0.001). Likewise, the thickness of each of the vaginal walls (anterior, posterior, right and left lateral) statistically differed between the two groups (p < 0.001). CONCLUSION: Transvaginal ultrasound with intravaginal gel may be a feasible objective technique to assess genitourinary syndrome of menopause, showing clear differences in vaginal wall thickness between breast cancer survivors using aromatase inhibitors and premenopausal women. Possible correlations with symptoms or treatment response should be assessed in future studies.

Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause: The LIGHT Randomized Clinical Trial.

Importance: Survivors of breast cancer present more severe symptoms of genitourinary syndrome of menopause (GSM) than patients without history of breast cancer. Recently, new treatments, such as vaginal laser therapy, have appeared, but evidence of their efficacy remains scarce. Objective: To assess the safety and efficacy of carbon dioxide (CO2) vs sham vaginal laser therapy after 6 months of follow-up in survivors of breast cancer with GSM receiving aromatase inhibitors. Design, Setting, and Participants: This prospective double-blind sham-controlled randomized clinical trial with two parallel study groups was performed during October 2020 to March 2022 in a tertiary referral hospital. Survivors of breast cancer using aromatase inhibitors were assessed for eligibility, and eligible patients were randomized into the 2 treatment groups. Follow-up was conducted at 6 months. Data were analyzed in July 2022. Interventions: All patients from both groups were instructed to use the first-line treatment (FLT) based on nonhormonal moisturizers and vaginal vibrator stimulation. Patients for each group were allocated to 5 monthly sessions of fractional CO2 laser therapy (CLT) or sham laser therapy (SLT). Main Outcomes and Measures: The primary outcome was sexual function, evaluated through Female Sexual Function Index (FSFI) score. Other subjective measures of efficacy included a visual analog scale of dyspareunia, vaginal pH, a Vaginal Health Index, quality of life (assessed via Short-Form 12), and body image (assessed with the Spanish Body Image Scale). Objective measures of efficacy included vaginal maturation index, vaginal epithelial elasticity (measured in Pascals) and vaginal epithelial thickness (measured in millimeters). Measures were assessed before and after the intervention. Tolerance (measured on a Likert scale), adverse effects, and estradiol levels were recorded. Results: Among 211 survivors of breast cancer assessed, 84 women were deemed eligible and 72 women (mean [SD] age, 52.6 [8.3] years) were randomized to CLT (35 participants) or SLT (37 participants) and analyzed. There were no statistically significant differences between groups at baseline. At 6 months, both groups showed improvement in FSFI (mean [SD] score at baseline vs 6 months: CLT, 14.8 [8.8] points vs 20.0 [9.5] points; SLT, 15.6 [7.0] points vs 23.5 [6.5] points), but there was no significant difference between CLT and SLT groups in the improvement of sexual function evaluated through the FSFI test overall (mean [SD] difference, 5.2 [1.5] points vs 7.9 [1.2] points; P = .15) or after excluding women who were not sexually active (mean [SD] difference, 2.9 [1.4] points vs 5.5 [1.1] points; P = .15). There were also no differences between improvement of the 2 groups at 6 months of follow-up in the other assessed subjective outcomes, including dyspareunia (mean [SD] difference, -4.3 [3.4] vs -4.5 [2.3]; P = .73), Vaginal Health Index (mean [SD] difference, 3.3 [4.1] vs 5.0 [4.5]; P = .17), body image (mean [SD] difference, -3.7 [4.5] vs -2.7 [4.8]; P = .35), and quality of life (mean [SD] difference, -0.3 [3.6] vs -0.7 [3.2]; P = .39). Similarly, there were no differences in improvements in objective outcomes, including vaginal pH (mean [SD] difference, -0.6 [0.9] vs -0.8 [1.2]; P = .29), vaginal maturation index (mean [SD] difference, 10.2 [17.4] vs 14.4 [17.1]; P = .15), vaginal epithelial thickness (mean [SD] difference, 0.021 [0.014] mm vs 0.013 [0.012] mm; P = .30), vaginal epithelial elasticity (mean [SD] difference, -1373 [3197] Pascals vs -2103 [3771] Pascals; P = .64). There were significant improvements in the overall analysis regardless of group in many outcomes. The 2 interventions were well tolerated, but tolerance was significantly lower in the CLT group than the SLT group (mean [SD] Likert scale score, 3.3 [1.3] vs 4.1 [1.0]; P = .007). No differences were observed in complications or serum estradiol levels. Conclusions and Relevance: In this randomized clinical trial, vaginal laser treatment was found to be safe after 6 months of follow-up, but no statistically significant differences in efficacy were observed between CLT and SLT. Trial Registration: ClinicalTrials.gov identifier: NCT04619485.

Midterm postoperative results of mid-urethral slings. Role of ultrasound in explaining surgical failures.

INTRODUCTION: Surgical treatment for stress urinary incontinence (SUI) with mid-urethral sling (MUS) is considered to have a high success rate. However, between 5% and 20% of MUS fail, with inadequate surgical implantation being a possible cause of SUI persistence or recurrence. Misplacement of a MUS can be determined by pelvic floor ultrasound (PF-US). The aim of this study was to investigate the role of PF-US in patients with persistent or recurrent urinary incontinence (UI) symptoms after MUS surgery for SUI with a midterm follow-up. MATERIALS AND METHODS: A historical cohort study including women undergoing MUS surgery for SUI between 2013 and 2015 was designed. The primary outcome was to correlate the sonographic parameters of MUS with SUI cure (negative International Continence Society-Uniform Cough Stress Test, Incontinence Questionnaire-Short Form < 5 points and no symptoms of SUI), at 5 years postsurgery. Secondary outcomes were changes of maximum urethral closure pressure (MUCP) and symptoms of urgency urinary incontinence (UUI) at 1 and 5 years after surgery. RESULTS: Eighty-seven patients (80 transobturator-MUS, 7 retropubic-MUS) were included. At 5 years all patients referred improvement of UI and objective cure of SUI was demonstrated in 81.2%. The MUS was sonographically correct in 67 (98.5%) of the 68 patients with cure of SUI. The MUS was considered incorrectly placed in only 4 (28.6%) of the 14 patients with noncured SUI. MUCP decreased from 61.9 to 48.8 cmH2 O at 5 years of follow-up (p < 0.01) and up to 53% of women had UUI symptoms after surgery, with a nonsignificant decrease compared to baseline. CONCLUSION: Patients cured of SUI had sonographically correct MUS by PF-US. Less than one-third of cases of SUI persistence or recurrence after MUS surgery could be explained by a sonographically incorrect sling. Low urethral resistance and/or UUI symptoms could help to explain the remaining failures. Complete functional and anatomic studies, including urodynamics and PF-US, should be performed before deciding on the next management strategy in patients with SUI persistence or recurrence after MUS.

International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training.

INTRODUCTION AND HYPOTHESIS: This manuscript from Chapter 3 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) describes the current evidence and suggests future directions for research on the effect of pelvic floor muscle training (PFMT) in prevention and treatment of POP. METHODS: An international group of four physical therapists, four urogynecologists and one midwife/basic science researcher performed a search of the literature using pre-specified search terms on randomized controlled trials (RCTs) in Ovid Medline, EMBASE, CINAHL, Cochrane, PEDro and Scopus databases for publications between 1996 and 2021. Full publications or expanded abstracts in English or in other languages with abstracts in English were included. The PEDro rating scale (0-10) was used to evaluate study quality. Included RCTs were reviewed to summarize the evidence in six key sections: (1) evidence for PFMT in prevention of POP in the general female population; (2) evidence for early intervention of PFMT in the peripartum period for prevention and treatment of POP; (3) evidence for PFMT in treatment of POP in the general female population; (4) evidence for perioperative PFMT; (5) evidence for PFMT on associated conditions in women with POP; (6) evidence for the long-term effect of PFMT on POP. Full publications in English or in other languages with abstracts in English and expanded abstracts presented at international condition specific societies were included. Internal validity was examined by the PEDro rating scale (0-10). RESULTS: After exclusion of duplicates and irrelevant trials, we classified and included 2 preventive trials, 4 trials in the post-partum period, 11 treatment trials of PFMT for POP in the general female population in comparison with no treatment or lifestyle interventions, 10 on PFMT as an adjunct treatment to POP surgery and 9 long-term treatment trials. Only three treatment studies compared PFMT with the use of a pessary. The RCTs scored between 4 and 8 on the PEDro scale. No primary prevention studies were found, and there is sparse and inconsistent evidence for early intervention in the postpartum period. There is good evidence/recommendations from 11 RCTs that PFMT is effective in reducing POP symptoms and/or improving POP stage (by one stage) in women with POP-Q stage I, II and III in the general female population, but no evidence from 9/10 RCTs that adding PFMT pre- and post -surgery for POP is effective. There are few long-term follow-up studies, and results are inconsistent. There are no serious adverse effects or complications reported related to PFMT. CONCLUSIONS: There are few studies on prevention and in the postpartum period, and the effect is inconclusive. There is high-level evidence from 11 RCTs to recommend PFMT as first-line treatment for POP in the general female population. PFMT pre- and post-POP surgery does not seem to have any additional effect on POP. PFMT is effective and safe but needs thorough instruction and supervision to be effective.

Readjustable Sling in Women With Stress Urinary Incontinence and Hypomobile Urethra: Understanding the Mechanisms of Closure by Transperineal Ultrasound.

OBJECTIVES: To assess the postsurgical sonographic parameters of a readjustable sling (RAS) according to urinary incontinence (UI) symptoms after surgery and compare this RAS sonographic pattern with mid-urethral slings (MUS). METHODS: Observational, prospective multicenter study, including women undergoing stress urinary incontinence (SUI) surgery with RAS (Remeex®). The primary outcome was the association between UI symptoms and sonographic parameters measured by two-dimensional transperineal and high-frequency endovaginal ultrasound. We measured static parameters (bladder neck funneling, RAS position, symmetry, distance to the urethral lumen), and the movement of the sling on Valsalva. UI symptoms were measured with the postsurgical Incontinence Questionnaire-Short Form (ICIQ-UI-SF) questionnaire. We created two control groups including patients with transobturator-MUS (TOT-MUS) and retropubic-MUS (RT-MUS) to compare postsurgical sonographic parameters of RAS with MUS. RESULTS: Among the 55 women with RAS included, the postoperative ICIQ-UI-SF scores were significantly higher in patients with bladder neck funneling (15.0 (3.9) vs 10.6 (6.7); P = .020) and in those with discordant movement of RAS on Valsalva (14.6 (5.7) vs 10.3 (6.7); P = .045). Compared with the 109 women with TOT-MUS and the 55 with RT-MUS, RAS was more often located in the proximal urethra and farther from the urethral lumen. CONCLUSIONS: Postsurgical pelvic floor ultrasound demonstrated that in women with complex SUI and hypomobile urethra who underwent RAS (Remeex®) surgery, the presence of bladder neck funneling and discordant movement on Valsalva correlate with the persistence of UI symptoms. In these women, RAS is more often located in the proximal urethra and farther from the urethral lumen at rest in comparison with MUS.

Female sexuality before and after sacrocolpopexy or vaginal mesh: is vaginal length one of the key factors?

INTRODUCTION AND HYPOTHESIS: We aimed to demonstrate that laparoscopic sacrocolpopexy/cervicopexy (LSC-Cx) versus anterior vaginal mesh (AVM) results in a longer vaginal length without impacting sexual activity or function. METHODS: We performed a secondary analysis of sexual outcomes of a previous randomized control trial comparing LSC-Cx and AVM in 120 women (60/group) with symptomatic POP stage ≥ 3. We evaluated sexually active (SA) and non-sexually active women (NSA) using the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA-Revised (PISQ-IR) preoperatively and 1 year postoperatively. Multivariate logistic and linear regression models were built to assess the impact of different variables on sexual activity and function, respectively. RESULTS: Among 120 women included, no statistically significant differences were found between vaginal length and preoperative dyspareunia (20.7% AVM vs. 22,8% LSC-Cx) comparing SA to NSA women and LSC-Cx to AVM. Vaginal length was significantly longer after LSC-Cx versus AVM (p < 0.001). The postoperative dyspareunia rate was 17.2% AVM versus 10.5% LSC-Cx. Partnered women were significantly more likely to be SA than unpartnered women before (OR = 19.04; p = 0.006) and after surgery (OR = 36.28; p = 0.002). Only dyspareunia was independently associated with sexual function pre- (B = -0.431; p = 0.017) and postoperatively (B = -0.3 96; p = 0.007). CONCLUSIONS: Vaginal length was greater following LSC-Cx compared to AVM. While vaginal length has no impact on female sexuality pre- and postoperatively, the most important factors were "having a partner" for sexual activity and dyspareunia for sexual function. Persistence of dyspareunia was higher after AVM. LSC-Cx should be considered in women with POP undergoing mesh surgery with future sexual expectations.

Mid-term results of the Remeex® readjustable sling for female complex stress urinary incontinence and sonographic hypomobile urethra.

INTRODUCTION AND HYPOTHESIS: We aimed to evaluate the results of a readjustable sling (Remeex® system) among a selected group of women with complex stress urinary incontinence (SUI) with sonographic hypomobile urethra and assessing failure-related risk factors. METHODS: Observational, longitudinal, prospective cohort study, including patients who underwent surgery with the Remeex® system. The primary outcome was a binary outcome in change of one level or more of the severity of urinary incontinence symptoms according to the intervals of the Incontinence Questionnaire-Short Form (ICIQ-UI-SF) score (mild, moderate, severe and very severe). Secondary outcomes were postsurgical complications, absolute ICIQ-UI-SF, 24-h pad weight test (24-h PT), urodynamic SUI and Patient Global Impression of Improvement (PGI-I) score to evaluate subjective success. RESULTS: Among 120 women included, after surgery we found a 70% subjective success rate, a 76.7% decrease of urinary incontinence severity and a mean reduction of the 24-h PT of 109.6 ± 291.4 g. Women with post-surgical decreased severity of incontinence had lower mean body mass index (BMI) and 24-h PT than those without incontinence severity changes with statistically significant differences (p = 0.028 and p = 0.027, respectively). A logistic regression model demonstrated that a 1-point increase of BMI increased the risk of persistence of incontinence severity after surgery by 19% (OR = 1.19; 95% CI: 1.01-1.41; p = 0.040), and an increase of 10 g in the pre-surgical 24-h PT represented a 3% rise of the aforementioned risk (OR = 1.03; 95% CI: 1.01-1.06; p = 0.034). CONCLUSIONS: In patients with complex SUI and sonographic hypomobile urethra, use of a readjustable sling (Remeex® system) led to improvement of SUI. Patients with a greater BMI and pre-surgical 24-h PT showed worse results after surgery.

Sexual activity and function in women with advanced stages of pelvic organ prolapse, before and after laparoscopic or vaginal mesh surgery.

INTRODUCTION AND HYPOTHESIS: The differential impact of specific pelvic organ prolapse (POP) surgery on sexual activity and function is unknown. Our primary aim was to analyse sexual inactivity and function in women with symptomatic advanced stages of POP and the changes incurred after laparoscopic or vaginal mesh surgery. METHODS: We performed a secondary analysis of sexual outcomes of a previously published randomised controlled trial comparing laparoscopic sacrocolpopexy/cervicopexy (LSC-Cx) and anterior vaginal mesh (AVM) in 120 women (60/group) with symptomatic anterior POP stage ≥ 3 and apical ≥ 2. Sexual activity and function were assessed preoperatively and 1 and 2 years postoperatively using the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA-Revised (PISQ-IR). RESULTS: Sexual activity was recovered in 42.9% of non-sexually active (NSA) women 1 year postoperatively, mainly in women with higher preoperative POP-related subscale scores of the PISQ-IR, which indicated a negative preoperative sexuality by POP. Recovery of sexual activity was greater after LSC-Cx, albeit not significantly (2 years: 35.5% AVM vs. 45% LSC-Cx). Among sexually active (SA) women preoperatively remaining SA postoperatively, the difference in the mean PISQ-IR summary score significantly improved [mean baseline difference - 2 years; all: 0.3 (95% CI 0.1 to 0.5) p = 0.001; AVM 0.19 (95% CI -0.1 to -0.5) p > 0.05; LSC-Cx 0.37 (95% CI 0.1 to 0.7) p = 0.003]. Preoperative dyspareunia was significantly reduced after LSC-Cx (baseline: 24.6%, 2 years: 9.8%, p = 0.0448), but not after AVM (baseline: 20.7%, 2 years: 18.2%, p = 0.7385). CONCLUSIONS: Most women reported improved sexual activity and function 2 years after LSC-Cx or AVM, mainly because of enhanced POP-related subscales in both NSA and SA women. Recovery of sexual activity and improved sexual function were greater after LSC-Cx compared to AVM, likely related to less postoperative dyspareunia.

Cough stress tests to diagnose stress urinary incontinence in women with pelvic organ prolapse with indication for surgical treatment.

AIMS: To evaluate the diagnostic ability of different cough stress tests (CSTs) in women with pelvic organ prolapse (POP), performed during outpatient urogynaecological exams. METHODS: Prospective, multicentre observational study involving women on waiting lists for POP surgery. With a subjectively full bladder, patients were asked to perform five different CSTs: without prolapse reduction ([a] standing, followed by [b] semilithotomy position); keeping semilithotomy position with prolapse reduced (by [c] posterior speculum, followed by [d] pessary); [e] standing again with the pessary in place. Primary outcome was positive CST in at least one of the five CSTs. Bladder volume was measured and symptoms of stress urinary incontinence (SUI) were detected by two validated questionnaires. RESULTS: A total of 297 women completed all CSTs and were included in the analyses. Mean (SD) age, parity, and body mass index were 64.8 (9.9) years, 2.7 (1.3) deliveries, and 26.6 (3.4) kg/m2 , respectively. In total, 99 women (33.3%) reported SUI symptoms. At least one positive CST was recorded in 152 patients (51.1%), and in 90 (59.2%) of these 152, a positive CST was observed only when POP was reduced (occult SUI). The CST was positive in 92 (92.9%) of the 99 patients with coexisting SUI symptoms and in 60 (30.3%) of the 205 asymptomatic patients. The percentage of patients with a positive CST was significantly lower when bladder volume was <200 mL vs ≥200 mL (P = .046). CONCLUSIONS: The identification of urinary leakage cases with CSTs is best achieved using multiple different patient positions, different prolapse reduction methods, and bladder volumes ≥200 mL.