A randomized trial comparing vaginal laser therapy and pelvic floor physical therapy for treating women with stress urinary incontinence.

INTRODUCTION: Female stress urinary incontinence (SUI) is considered a major public health issue. Physical therapy is an important conservative treatment; however, it is primarily limited by poor long-term compliance. Furthermore, surgical treatment entails significant risks. Therefore, new treatment techniques must be identified. OBJECTIVE: To compare the use of laser therapy and pelvic floor (PF) physical therapy for treating postmenopausal women with SUI. METHODS: This pilot study enrolled 40 women with a clinical and urodynamic diagnosis of SUI who were randomized into two groups: those who received erbium-doped yttrium-aluminum-garnet (Er:YAG) laser therapy implemented over three sessions with a 1-month interval (n = 20) and those who received physical therapy with supervision twice a week for 3 months (n = 20). In total, 16 women completed the treatment in each group. The patients were assessed for PF function using the modified Oxford scale and for pelvic organ prolapse using the Pelvic Organ Prolapse Quantification System. The 1-h pad test and quality of life questionnaires, King's Health Questionnaire (KHQ), and Incontinence Quality of Life (IQOL) were also administered. Patients were re-evaluated at 1, 3, 6, and 12 months after treatment. RESULTS: The mean patient age was 62.7 ± 9.1 and 57.9 ± 6.1 years, median Oxford score at baseline was 3 (2-4.5) and 4 (3-4), mean IQOL score was 79.8 ± 17 and 74.6 ± 18 for physical therapy group (PTG) and laser group (LG), respectively. For the amount of urine leak in the 1-h pad test evaluation, we found significance for the interaction of group and time points only for the Laser intragroup. The cure rate, that is, the rate of reaching an insignificant score in the pad test, at 6 and 12 months was 43.75% and 50% in PTG and 62.5% and 56.25% in the LG, respectively (p > 0.05). IQOL scores demonstrated considerable improvement in both groups (p > 0.05). Upon comparing the initial and follow-up results, the LG showed an improvement at all consultations, whereas the PTG showed improvements at 1, 3, and 6 months but not at 12 months after treatment. KHQ analysis revealed a considerable improvement in the quality of life (QOL) of patients over time, with no substantial difference between the groups. QOL comparison before and after treatment revealed that the vaginal LG improved more consistently in some domains. Only the PTG showed a significant increase in the mean Oxford score from pretreatment to 1 and 3 months after treatment (p < 0.001 and p = 0.002, respectively). However, no statistically significant difference was observed between the groups. CONCLUSION: Both treatments are safe and have a positive influence on the impact of UI on patients' QOL. The laser caused a greater reduction in the urinary loss, as measured using the weight of pad test, at 6-month and 12-month after treatment without difference with PTG at the end of the follow-up.

Comparison between anterior and posterior vaginal approach in apical prolapse repair in relation to anatomical structures and points of fixation to the sacrospinous ligament in fresh postmenopausal female cadavers.

INTRODUCTION AND HYPOTHESIS: The high prevalence of pelvic organ prolapse (POP) in women requires attention and constant review of treatment options. Sacrospinous ligament fixation (SSLF) for apical prolapse has benefits, high efficacy, and low cost. Our objective is to compare anterior and posterior vaginal approach in SSLF in relation to anatomical structures and to correlate them with body mass index (BMI). METHODS: Sacrospinous ligament fixation was performed in fresh female cadavers via anterior and posterior vaginal approaches, using the CAPIO®SLIM device (Boston Scientific, Natick, MA, USA). The distances from the point of fixation to the pudendal artery, pudendal nerve, and inferior gluteal artery were measured. RESULTS: We evaluated 11 cadavers with a mean age of 70.1 ± 9.9 years and mean BMI 22.4 ± 4.6 kg/m2. The mean distance from the posterior SSLF to the ischial spine, pudendal artery, pudendal nerve, and inferior gluteal artery were 21.18 ± 2.22 mm, 17.9 ± 7.3 mm, 19.2 ± 6.8 mm, and 18.9 ± 6.9 mm respectively. The same measurements relative to the anterior SSLF were 19.7 ± 2.7 mm, 18.6 ± 6.7 mm, 19.2 ± 6.9 mm, and 18.3 ± 6.7 mm. Statistical analysis showed no difference between the distances in the two approaches. The distances from the fixation point to the pudendal artery and nerve were directly proportional to the BMI. CONCLUSIONS: There was no difference in the measurements obtained in the anterior and posterior vaginal approaches. A direct correlation between BMI and the distances to the pudendal artery and pudendal nerve was found.

Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS).

INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). METHODS: RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. RESULTS: Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman's rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. CONCLUSIONS: Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.

Comparison of stress urinary incontinence between urban women and women of indigenous origin in the Brazilian Amazon.

INTRODUCTION AND HYPOTHESIS: This study compared two populations in the Brazilian Amazon, one comprising urban women and the other indigenous origin women from a riparian population, to assess the prevalence of and risk factors associated with stress urinary incontinence (SUI). METHODS: Following sample calculation, 120 indigenous and 260 urban women underwent evaluations including medical history, UI-oriented physical examination, pelvic organ prolapse, and functional assessment of the pelvic floor. Women with complaints of SUI underwent a urodynamic study and completed a quality of life questionnaire (King's Health Questionnaire). Univariate ORs were calculated, and multiple logistic regression models were then built using the stepwise backward method. RESULTS: The prevalence of SUI was similar in both groups (25.8% in indigenous origin women and 20.4% in the urban group (P > 0.05). The parity and number of spontaneous deliveries and home births were higher in the indigenous origin group. Multivariate analysis showed a decreased prevalence of SUI in patients with modified Oxford Scale scores ≥ 3. Women with homebirths had a 3.45-fold higher likelihood of having SUI than women with hospital deliveries (OR 3.45 -CI 1.78-6.70). Quality of life was worse in the domains of SUI impact, hindering daily and physical activities as well as jeopardizing personal and emotional relationships in urban women. CONCLUSIONS: No significant difference in SUI was observed between the groups, despite significantly higher risk factors for SUI in the indigenous origin group.

Patient-reported outcomes and outcome measures in childbirth perineal trauma research: a systematic review.

INTRODUCTION AND HYPOTHESIS: In evaluating the effectiveness of interventions in perineal trauma research, outcomes reported by patients should have a prominent focus. There is no international consensus regarding the use of either patient-reported outcomes (PROs) or tools used to determine these outcomes (patient-reported outcome measures, PROMs). The objective was to evaluate the selection, reporting and geographical variations of PROs and PROMs in randomised controlled trials (RCTs) on perineal trauma. METHODS: We performed a systematic review of RCTs in perineal trauma research evaluating outcome and outcome measure reporting. We identified PROs and PROMs and grouped PROs into domains and themes, a classification system based on a medical outcome taxonomy. RESULTS: Of 48 included RCTs, 47 reported PROs. In total, we identified 51 PROs. Outcome reporting consistency was low, with 27 PROs reported only once. Nine PROs were reported more than five times, the most frequent being perineal pain, with no geographical variation in reporting. Four themes encompassing 12 domains were identified. The most frequently reported theme was "Clinical", with 25 PROs grouped within four domains. "Resource use" and "Adverse events" themes were rarely reported, with only five PROs. PROMs also exhibited variation. Most common were visual analogue scale (VAS; 100 mm), Cleveland Clinic Continence Score, The Faecal Incontinence Quality of Life scale, VAS (0-10) and the McGill Pain Questionnaire. CONCLUSIONS: Significant heterogeneity in PROs and PROMs was observed among RCTs. Despite inconsistency, PROs are the most prevalent outcome in perineal trauma research. Patient-reported adverse events are underreported. Their use in determining the effectiveness and safety of interventions makes their integration important in perineal trauma core outcome sets. Identification and grouping of outcomes will assist future core outcome consensus studies.

Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets.

INTRODUCTION AND HYPOTHESIS: Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. METHODS: Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. RESULTS: Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). CONCLUSIONS: Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.

A guide to physiotherapy in urogynecology for patient care during the COVID-19 pandemic.

INTRODUCTION AND AIM: Physiotherapy in urogynecology faces challenges to safely continuing its work, considering the adoption of social distancing measures during the COVID-19 pandemic. Some guidelines have already been published for urogynecology; however, no specific documents have been produced on physiotherapy in urogynecology. This article aimed to offer guidance regarding physiotherapy in urogynecology during the COVID-19 pandemic. METHODS: A group of experts in physiotherapy in women's health performed a literature search in the Pubmed, PEDro, Web of Science and Embase databases and proposed a clinical guideline for physiotherapy management of urogynecological disorders during the COVID-19 pandemic. This document was reviewed by other physiotherapists and a multidisciplinary panel, which analyzed the suggested topics and reached consensus. The recommendations were grouped according to their similarities and allocated into categories. RESULTS: Four categories of recommendations (ethics and regulation issues, assessment of pelvic floor muscle function and dysfunction, health education and return to in-person care) were proposed. Telephysiotherapy and situations that need in-person care were also discussed. Regionalization is another topic that was considered. CONCLUSION: This study provides some guidance for continuity of the physiotherapist's work in urogynecology during the COVID-19 pandemic, considering the World Health Organization recommendations and the epidemiological public health situation of each region. Telephysiotherapy can also be used to provide continuity of the care in this area during the COVID-19 pandemic, opening new perspectives for physiotherapy in urogynecology.

Content and functionality features of voiding diary applications for mobile devices in Brazil: a descriptive analysis.

INTRODUCTION AND HYPOTHESIS: A voiding diary is a method to investigate lower urinary tract symptoms. The purpose was to elaborate a descriptive analysis of nonpaid voiding diaries for mobile applications and to compare them regarding their quality. METHODS: We searched the platforms of iTunes (Apple Inc., Brazil) and Google Play (Google Inc., Brazil) using the keywords: "voiding diary," "bladder diary," "urinary diary," "urinary incontinence," and "pelvic floor." Inclusion criteria were: apps free of charge and specific for voiding diaries in the Portuguese, Spanish, French, or English language. Exclusion criteria were: access or technical problems and pediatric apps. We quantitatively analyzed and compared the apps with each other according to their functionality features and voiding diary topics (type and volume of fluid intake, voiding episodes and volume, type and episodes of incontinence, amount of leakage, urgency, and use of pads and nocturia). We rated the apps using the Mobile App Rating Scale (MARS), whose scores for each feature vary from 1 (worst score) to 5 (best score). RESULTS: Fifty-five apps were eligible; 16 were included for analyses. None presented all 11 topics of the voiding diary, and the median number of available features was 6 (3.75-7). "Incontinence episodes" was present in eight apps, and "nocturia" was present in five. The mean score of apps ranged between 1.7 and 4.5. CONCLUSION: There is variation in the content of voiding topics among the apps. Patients and professionals should choose the app based on the topics of most or particular interest.

Latin American consensus on uncomplicated recurrent urinary tract infection-2018.

An estimated 20-30% of adult women who experience an initial urinary tract infection (UTI) will have recurrent infection. In these patients, prophylaxis may be considered to improve their quality of life and control overuse of antibiotics. Despite this need, there is currently no Latin American consensus on the treatment and prophylaxis of recurrent UTIs. This consensus, signed by a panel of regional and international experts on UTI management, aims to address this need and is the first step toward a Latin American consensus on a number of urogynecological conditions. The panel agrees that antibiotics should be considered the primary treatment option for symptomatic UTI, taking into account local pathogen resistance patterns. Regarding prophylaxis, immunoactive therapy with the bacterial lysate OM-89 received a grade A recommendation and local estrogen in postmenopausal women grade B recommendation. Lower-grade recommendations include behavior modification and D-mannose; probiotics (Lactobacilli), cranberries, and hyaluronic acid (and derivatives) received limited recommendations; their use should be discussed with the patient. Though considered effective and receiving grade A recommendation, antimicrobial prophylaxis should be considered only following prophylaxis with effective non-antimicrobial measures that were not successful and chosen based on the frequency of sexual intercourse and local pathogen resistance patterns.

A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research.

BACKGROUND: More than 85% of women sustain different degrees of trauma during vaginal birth. Randomized controlled trials on childbirth pelvic floor trauma have reported a wide range of outcomes and used different outcome measures. This variation restricts effective data synthesis, impairing the ability of research to inform clinical practice. The development and use of a core outcome set (COS) for childbirth pelvic floor trauma aims to ensure consistent use of outcome measures and reporting of outcomes. METHODS: An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women's Health, including academic community members, researchers, healthcare professionals, policy makers and women with childbirth pelvic floor trauma will lead the development of this COS. Relevant outcome parameters will be identified through comprehensive literature reviews. The selected outcomes will be entered into an international, multi-perspective online Delphi survey. Subsequently and based on the results of the Delphi surveys consensus will be sought on 'core' outcomes. DISCUSSION: Dissemination and implementation of the resulting COS within an international context will be supported and promoted. Embedding the COS for childbirth pelvic floor trauma within future clinical trials, systematic reviews, and clinical practice guidelines is expected to enrich opportunities for comparison of future clinical trials and allow better synthesis of outcomes, and will enhance mother and child care. The infrastructure created by developing a COS for childbirth pelvic floor trauma could be leveraged in other settings, for example, advancing research priorities and clinical practice guideline development.

Validation of the Brazilian Portuguese version of the pelvic floor bother questionnaire.

INTRODUCTION AND HYPOTHESIS: The Pelvic Floor Bother Questionnaire (PFBQ) was designed to identify the presence and degree of bother associated with common pelvic floor symptoms. The PFBQ can be used in clinical practice and for research purposes, but it is not available in Brazilian Portuguese. We aimed to validate a cross-culturally adapted Brazilian Portuguese version of the PFBQ. METHODS: A pilot-tested version of the PFBQ translated from English was evaluated with Brazilian patients suffering from pelvic floor disorders. Internal reliability, test-retest reliability, validity, and responsiveness to change were assessed. RESULTS: A total of 147 patients (mean age, 60.49 years) were enrolled in the study. The Brazilian Portuguese version of the PFBQ demonstrated good reliability (α = 0.625; ICC = 0.981). There was strong agreement beyond chance for each item (κ = 0.895-1.00). The PFBQ correlated with stage of prolapse (p < 0.01), number of urinary (ρ = 0.791, p < 0.001) and fecal (ρ = 0.78, p < 0.001) incontinence episodes, and obstructed defecation (ρ = 0.875, p < 0.001). CONCLUSIONS: The Brazilian Portuguese version of the PFBQ is a reliable, valid, and user-friendly instrument that can be used for assessing the presence and severity of pelvic floor symptoms in clinical and research settings in Brazil.

Hormonal oral contraceptive influence on isolation, Characterization and cryopreservation of mesenchymal stem cells from menstrual fluid.

The purpose of the study was to evaluate whether the intake of hormonal oral contraceptive influences the viability of mesenchymal stem cell. Sixteen healthy female volunteers with regular menstrual cycles were invited to participate. Menstrual fluid was collected on the day of maximum flux, and collected cells were analyzed by a 'minimal standard' for MSC characterization: plastic adherence, trilineage (adipogenic, osteogenic, chondrogenic) in vitro differentiation and a minimalistic panel of markers assessed by flow cytometry (CD731, CD901, CD1051, CD34-, CD45-) using monoclonal antibodies. The participants were divided into two groups: Group 1 - no hormonal contraceptive use; Group 2 - hormonal oral contraceptive use. The median of the menstrual fluid volume was 5.0 and the median number of cells was 5.2 × 106. Median of cell viability was 89.3%. After culture, mesenchymal stem cells increased from 0.031% of the total cells to 96.9%. The cells formed clusters and reached confluence after 15-21 days of culture in the first passage. In the second passage, clusters and the confluence were observed after 3 days of culture. No difference was observed between the groups. Our data suggest that oral hormonal contraceptive intake maintains the viability of mesenchymal stem cells from menstrual fluid.

Urinary incontinence in female athletes: a systematic review.

INTRODUCTION AND HYPOTHESIS: People are increasingly aware of healthy lifestyles. Extenuating practice can injure the pelvic floor. Urinary incontinence (UI) is a prevalent condition in women whether they exercise professionally or not. The most common symptom is stress UI. It is reported in a large variety of sports and may interfere with everyday life or training, leading athletes to change or compromise their performance or risk compromising it. We aimed to assess the prevalence of UI in female athletes and to determine whether the type of sport might also influence UI. METHODS: A systematic review of the literature was performed by searching PubMed, the Cochrane Library, and LILACS up to 23 January 2017. The search strategy included the keywords pelvic floor disorders, urinary incontinence, athletes, and sports. The inclusion criterion was studies of women who performed any kind of sport with a prevalence of UI. The subjects were female, with no restriction for age, sport modality, or frequency of training. The outcome was prevalence of UI. RESULTS: The search identified 385 studies, 22 of which met the methodologic criteria for complete analysis. In this review, 7507 women aged 12 to 69 years were included. Only five studies compared physically active women to controls. Every study included high or moderate impact activities involving jumping, fast running, and rotational movements. In total, 17 sport modalities were analyzed. The prevalence of UI varied from 5.56% in low-impact activity to 80% in trampolining. In athletes, the prevalence of incontinence ranged from 10.88% to 80%, showing that the amount of training influences UI symptoms. High-impact activities showed a 1.9-fold prevalence over medium-impact activities and 4,59-fold prevalence over impact activities. Factors such as hormone use, smoking, or menopausal status could not be assessed since they were not detailed in most of the studies. CONCLUSION: These data suggest that sports practice increases the prevalence of UI and that the type of activity performed by women also has a bearing on the disorder.

Management of apical compartment prolapse (uterine and vault prolapse): A FIGO Working Group report.

AIM: Apical prolapse includes descent of the uterus, vagina cuff, or rarely solely of the cervix. It is estimated that women have an 11-19% life-time risk of undergoing surgery for POP. This rate is projected to increase over the next 2-3 decades. In this FIGO working group report we address the conservative and surgical treatment options for apical prolapse. METHODS: The FIGO working group "Pelvic Floor Medicine and Reconstructive Surgery" describes the different treatments for apical prolapse based on the literature evidence, the cost-effectiveness, the degree of difficulty and summed them up with an experts recommendation. RESULTS: Among the conservative treatment options, pessaries are the most successful options since centuries with a low complication rate and low costs. Among the vaginal operative procedures the sacrospinous ligament fixation (SSLF) and the uterosacral ligament suspension (USLS) show comparable outcomes and efficacy with a different, however, rather low complication pattern and a favorable cost-benefit profile. Sacrocolpopexy, independent on the open abdominal, laparoscopic, or robotic-assisted laparoscopic technique has a good durability and quality of life performance. The minimal invasive techniques are as effective as the open abdominal techniques and there is no difference in mesh exposure. CONCLUSION: Vaginal procedures are well described procedures with favorable outcomes and cost-benefit profiles. Sacral colpopexy has a high-effectivity; data on the route of performance and long-term outcome are awaited. The cost with mesh implants are higher compared to the operations with autologous tissue or any conservative treatment and further studies are recommended to evaluate the cure rates in the span of decades and the possible long-term mesh complications. Neurourol. Urodynam. 36:507-513, 2017. © 2015 Wiley Periodicals, Inc.

Should prophylactic anti-incontinence procedures be performed at the time of prolapse repair? Systematic review.

INTRODUCTION AND HYPOTHESIS: Women with high-grade pelvic organ prolapse (POP) are considered at risk of developing postoperative stress urinary incontinence (SUI) once the prolapse has been repaired. The probable explanation for patients remaining subjectively continent is that POP can cause urethral kinking or compression. We hypothesized that performing prophylactic anti-incontinence procedures during surgical POP correction in women with no symptoms for urinary incontinence (UI) may prevent SUI postoperatively. METHODS: A systematic review of randomized trials was performed. Participants were women with severe POP and no symptoms of SUI. The primary outcomes were UI or treatment for this condition after the surgical procedure. Results are presented as relative risk (RR), with 95% confidence interval (95% ). RESULTS: Initially, 5,618 studies were identified by the search strategy, but only seven trials met the inclusion criteria. We performed a meta-analysis with common variables of studies and with the same scale of quantification. We found that performing an anti-incontinence procedure at the same time of prolapse repair reduced the incidence of SUI postoperatively (RR 0.51; 95% CI 0.38-0.68). However, when the types of anti-incontinence procedure were analyzed separately, we found different results. The subgroup of patients who underwent retropubic midurethral sling surgery was the only group that benefited from the anti-incontinence procedure, with a decrease in the incidence of SUI (RR 0.09; 95% 0.02-0.36). CONCLUSIONS: Prophylactic treatment of women with severe POP using retropubic midurethral sling was the only procedure that reduced the risk of UI.

Multicenter, randomized trial comparing native vaginal tissue repair and synthetic mesh repair for genital prolapse surgical treatment.

INTRODUCTION AND HYPOTHESIS: This trial aimed to compare the outcomes of native vaginal tissue repair versus polypropylene mesh repair for the treatment of severe genital prolapse. METHODS: This multicenter randomized trial included 184 women, with POP-Q stage 3 or 4. They were randomly assigned to undergo surgical treatment using native tissue repair (n = 90) or synthetic mesh repair (n = 94). Native tissue repair surgery was performed according to site-specific defects, including sacrospinous ligament fixation for apical defects. Mesh repair (Prolift™) was performed in accordance with manufacturer recommendations. Hysterectomy was performed in all cases of uterine prolapse. Statistical tests were used to compare between-group and within-group differences before the surgery and at 1-year follow-up. We considered cure to have occurred when the POP-Q point evaluation was equal to or less than 0 and POP-Q point C better than or equal to half the total vaginal length (TVL) after 1 year. The patients answered the Prolapse Quality-of-Life Questionnaire (PQoL) and the Sexual Quotient Female Version (QS-F) questionnaire. RESULTS: Both groups were homogeneous preoperatively. There were no differences between the groups in operative time, complications or pain. At 1-year follow-up, anatomical cure rates were better in the mesh group in the anterior compartment (p = 0.019). Significant improvement in PQoL scores at 1-year follow up were observed in each group; between-group comparisons of changes in PQoL scores revealed greater improvement in the mesh group. CONCLUSION: Both techniques were effective. Anatomical efficacy was superior in the mesh group regarding the anterior compartment; quality of life changes were also greater in the mesh group. Complications were significantly higher in the mesh group.

A randomized clinical trial comparing internal and external pessaries in the treatment of pelvic organ prolapse in postmenopausal women: A pilot study.

INTRODUCTION AND HYPOTHESIS: Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women. METHODS: This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment. RESULTS: The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044). CONCLUSIONS: The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.

A meta-synthesis of qualitative studies on stress urinary incontinence in women for the development of a Core Outcome Set: A systematic review.

OBJECTIVE: Given the high variation of perceptions of women with stress urinary incontinence (SUI), qualitative meta-synthesis in this field appears warranted. We aimed to synthesize evidence on women's experiences of SUI by analyzing qualitative data. METHODS: A literature search of Medline, Embase, Scopus, PsycInfo, and CINAHL databases was performed by a CHORUS Working Group, from inception to August 2020. Qualitative studies on women's perspectives on SUI were included. Thematic analysis was used as a conceptual approach to analyze the data and develop a set of overarching themes. The quality of studies was assessed based on the Critical Appraisal Skills Program tool. RESULTS: Seven studies were included. Six themes encompassing women's perspectives on SUI emerged: experiencing SUI, awareness of SUI, treatments for SUI, sexuality, communication, and psychosocial effects. The quality appraisal of the studies showed good coherence. CONCLUSION: This study revealed six overarching themes, of which treatment had the highest prevalence. Assessment of women's perceptions of SUI in the context of a qualitative meta-synthesis may inform policy and practice around this condition, may guide and help set research priorities, and will ideally contribute to the development of a Core Outcome Set for SUI.

Outcome reporting in trials on conservative interventions for pelvic organ prolapse: A systematic review for the development of a core outcome set.

BACKGROUND: Significant risk of bias and limitations in outcome selections in trials evaluating conservative treatments for the management of Pelvic Organ Prolapse (POP) have been highlighted and preclude comparability of outcomes, synthesis of primary studies and high quality evidence. OBJECTIVES: As systematic review of the reported outcomes is the first step in the process of development of a Core Outcome Set (COS), we aimed to systematically review reporting of outcomes and outcome measures in Randomised Control Trials (RCTs) on conservative treatments for POP and develop an inventory of them for consideration as core outcome and outcome measures sets. We evaluated methodological quality, outcome reporting quality and publication characteristics and their associations among published RCTs. STUDY DESIGN: Systematic review of RCTs identified from the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE and MEDLINE (Pubmed). RCTs evaluating the effectiveness of conservative interventions for the management of POP were considered for inclusion. Outcomes and outcome measures were obtained from the RCTs and an inventory was created. Outcomes were grouped in domains and themes. Methodological quality, outcome reporting quality and publication characteristics were evaluated and statistically analysed. RESULTS: Twenty-five trials (3179 women) were included and reported 31 outcomes and 50 outcome measures. Reporting rates of the outcomes investigated ranged between 4% and 56%. The most commonly reported outcome domains were patient reported symptoms, stage of POP expressed as POP-Q stage, and quality of life. Univariate analysis demonstrated no significant correlations of methodological and outcome reporting parameters. CONCLUSIONS: There is a need to increase comparability of RCTs. Reporting standardized outcomes included in a COS for conservative interventions for POP will facilitate the comparability across RCTs. While the process of developing COS is in progress, we propose the interim use of the three most commonly reported outcomes in each domain: patient-reported outcomes (symptom distress including bowel and urinary symptoms, sexual function), stage of prolapse and quality of life parameters using validated questionnaires (Pelvic Floor Distress Inventory 20 (PFDI-20), Pelvic Floor Impact Questionnaire/Health related quality of life (PFIQ-7/HRQOL) and Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7).

Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study.

BACKGROUND: Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring a minimum of outcomes important to all stakeholders, primarily women requesting or having experienced cosmetic gynecological interventions. OBJECTIVE: This protocol describes the methods used in developing a COS and COMS for cosmetic gynecological interventions. METHODS: An international steering group within CHORUS, including health care professionals, researchers, and women with experience in cosmetic gynecological interventions from 4 continents, will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. These potential COS and COMS will be entered into an international, multi-perspective web-based Delphi survey where Delphi participants judge which domains will be core. A priori thresholds for consensus will get established before each Delphi round. The Delphi survey results will be evaluated quantitatively and qualitatively in subsequent stakeholder group consensus meetings in the process of establishing "core" outcomes. RESULTS: Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed. CONCLUSIONS: This protocol presents the steps in developing a COS and COMS for cosmetic gynecological interventions. Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to enhancing the value of research and improving overall patient care. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) 1592; https://tinyurl.com/n8faysuh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28032.