ImportanceSurvivors 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.ObjectiveTo 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 ParticipantsThis 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.InterventionsAll 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 MeasuresThe 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.ResultsAmong 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 RelevanceIn 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 RegistrationClinicalTrials.gov identifier: NCT04619485

e-Health may enhance self-management of pelvic floor muscle training (PFMT) to treat stress urinary incontinence (SUI). It is crucial to involve patients in planning, developing and monitoring the optimal e-Health solution. This research aims to describe patient-centered innovation in an early developmental stage of the WOMEN-UP solution. We conducted a qualitative study through a self-developed questionnaire in 22 women with SUI, to define system requirements from a patient’s perspective. The first prototype of the WOMEN-UP solution was developed. It was tested by 9 patients in a usability study (think-aloud protocol and retrospective interviews). Patient preferences regarding the possible use of an e-Health solution with serious games for PFMT were: (1) to receive feedback about PFMT; (2) convenient home-use; (3) increasing motivation; (4) available in medical centers. Identified usability aids (31) reassured our design-development plan, which considered the biofeedback and serious games as key factors. Patient’s perspective detected some unexpected issues related to the calibration and serious games, involving a change in the ongoing development to get an improved WOMEN-UP solution; the value of patient-centered innovation during the development of an e-Health solution for PFMT (WOMEN-UP solution). To identify patients’ unmet needs, we proposed a longitudinal approach for the future eHealth-related patient-centered innovations.

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.

BackgroundObstetric anal sphincter injuries (OASIS) are associated with sexual dysfunction and a lower likelihood of sexual activity in the postpartum period. The aim of the present study was to compare coital resumption and the variables influencing this activity after delivery in women with and without a history of obstetric anal sphincter injury (OASIS) and according to the mode of delivery.MethodsA prospective, observational, case-control study was performed at 6 months postpartum in 318 women: 140 with a history of primary repaired OASIS and 178 women without OASIS. Demographic and obstetric data, breastfeeding, and symptoms of urinary and anal incontinence were collected. Patients were asked about coital resumption and completed the validated specific Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12). Continuous and non-continuous variables were compared using ANOVA and the Fisher exact tests, respectively. A multivariate logistic regression model and a multiple regression analysis were constructed to assess the impact of demographic and clinical variables on the percentage of coital resumption and on the PISQ-12 score, respectively.ResultsAfter a spontaneous delivery (SD), patients without OASIS showed a higher percentage of coital resumption than those with OASIS (98% vs. 77%; p = 0.003), and the PISQ-12 score was also higher (p < 0.001). PISQ-12 score was better in women with SD compared to those with operative vaginal delivery (OVD)(p < 0.001), independently of the history of OASIS. Current breastfeeding, a higher Wexner score and OVD negatively influenced the PISQ-12 score.ConclusionsAfter SD, women with OASIS resumed coital activity later than women without OASIS. Women with OVD resumed coital activity later, and had a lower PISQ-12 score than women with SD.