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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).

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. 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. 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. 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.

AIMS To systematically evaluate the content and quality of national and international clinical guidelines on pelvic organ prolapse (POP). METHODS We searched medical databases and organizations websites, to identify national and international guidelines on diagnosis and management of POP. Five authors independently assessed guidelines using the validated AGREE II tool. Its six domains include (1) scope and purpose, (2) stakeholder involvement, (3) rigor of development, (4) clarity of presentation, (5) applicability, and (6) editorial independence. RESULTS Eight guidelines met the inclusion criteria. Three hundred and thirteen different recommendations were identified. One hundred and ninety-nine recommendations were comparable across guidelines. Thirty-one recommendations were not supported by research evidence. Assessment by history and physical examination using the POP quantification system and consideration of imaging were recommendations featuring in all guidelines. Conservative treatment recommendations namely pelvic floor muscle training and vaginal pessaries were also found in all guidelines. Regarding surgical management, patient counseling, treating only symptomatic POP, consideration of apical fixation during surgical treatment, and use of biological or synthetic implants in recurrent cases were recommendations in all guidelines. Overall, the highest median scores were in the domains "scope and purpose" and "rigor of development". The lowest median score was for applicability (28.3%). Although the median score of "editorial independence" was high (85.4%), variability was also substantial (interquartile range: 12.5-100). CONCLUSION We identified variations in quality and deficiencies in certain areas, especially "applicability" and "editorial independence." Improvements in these key domains may enhance the quality and clinical impact of clinical practice guidelines.

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.

Background Recent systematic reviews have demonstrated wide variations on outcome measure selection and outcome reporting in trials on surgical treatments for anterior, apical and mesh prolapse surgery. A systematic review of reported outcomes and outcome measures in posterior compartment vaginal prolapse interventions is highly warranted in the process of developing core outcome sets. Objective To evaluate outcome and outcome measures reporting in posterior prolapse surgical trials. Search strategy We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). Selection criteria Randomized trials evaluating the efficacy and safety of different surgical interventions for posterior compartment vaginal prolapse. Data collection and analysis Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted relevant data. Methodological quality, outcome reporting quality and publication characteristics were evaluated. Main results Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%). Conclusions Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness. Prospero CRD42017062456.

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.

BACKGROUND Several meta-analyses have identified methodological limitations in female stress urinary incontinence (SUI) trials, precluding the synthesis of primary studies and high-quality evidence. OBJECTIVES Evaluation of outcome measure selection and outcome reporting in randomised controlled trials (RCTs) on surgery for SUI. SEARCH STRATEGY Systematic review of RCTs identified from bibliographical databases, including Medline, Cochrane, and EMBASE. SELECTION CRITERIA Randomised controlled trials evaluating the efficacy and safety of surgical interventions for the management of female SUI. DATA COLLECTION AND ANALYSIS Two researchers independently assessed the included studies and documented outcomes. MAIN RESULTS Overall, 108 studies were identified that included 422 reported outcomes and 119 outcome measures. The three most common outcomes were cure rates (87 studies), quality of life (85 studies), and overactive bladder (78 studies). The median methodological quality rating was 3 (range 0-3) and the outcome reporting quality rating was 3 (range 0-5). Multinomial logistic regression analysis revealed that the methodological quality and use of validated questionnaire were significant predictors of the quality of outcome reporting (β = 0.538, P

Interstitial cystitis (IC) and bladder pain syndrome (BPS) are challenging and encompassing hypersensitivity disorders of the lower urinary tract. A variety of national and international guidelines have been published including guidance on nomenclature, definitions, etiopathology, diagnostics and treatment. A lack of universally established clinical guidance is apparent. The aim of this review is to evaluate key guidelines on this area of practice, identify variations, compare their recommendations and grade them using AGREE II. Literature searches were performed using the PUBMED and CINAHL database from January 1, 1983, to December 1, 2018, referring to the search strategy of AUA. Ten national and international guidelines were included into the analysis. We assessed the guidelines with the updated AGREE II. Symptoms congruent in all guidelines are: pain, pressure, discomfort and frequency, urgency and nocturia. Urinalysis is a prerequisite for diagnostics, cystoscopy for most and urodynamics not part of the routine assessment. Treatment options are recommended stepwise. The highest level of evidence and consensus was identified for oral therapies. Nine guidelines had an overall quality score ≥ 50% and three scored ≥ 70% (AUA, GG, RCOG). The guidelines are congruent in symptom reporting, quite congruent in diagnostics and vary to a high degree on treatment recommendations. The complexity of BPS and emerging evidence indicate the need for regular updating of the guidelines and a wider consensus.

Objective To systematically evaluate the content and quality of national and international guidelines on vaginal mesh procedures for pelvic organ prolapse (POP). Methods We searched PubMed, Medline, Web of Science, and ScienceDirect from inception to March 2020 and organizations' websites. The quality of the guidelines was assessed independently by six appraisers using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Results Five guidelines were included. Most guidelines recommended individualized treatments, clinical observation, and conservative treatment for asymptomatic women discouraging the use of mesh. Vaginal pessary and pelvic floor muscle training are unanimously considered effective treatments. Only two guidelines recommended weight loss. Each guideline recommended patient counseling supported by data on success rates and complications. Most guidelines highlighted the importance of a specialist experienced surgeon, multidisciplinary teams, and national/international registries. All guidelines highlighted potential benefits of the use of mesh and reported possible complications. The overall quality rating ranged between 4.2 and 6.3, suggestive of moderate to high quality. The highest mean score (92.5%) pertained to "Scope and Purpose" and "Clarity of Presentation", and the lowest to "Editorial Independence" (18%). Three out of five guidelines were "strongly recommended" by the appraisers. Conclusion Although most guidelines were of moderate to high quality, methodological applicability, stakeholder involvement, and editorial independence were domains with low scores.

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.

Pelvic floor trauma during childbirth is highly prevalent and is associated with long term risks of incontinence and pelvic organ prolapse. Societies and organizations have published clinical guidelines in order to standardise and improve the management of perineal care. The aim of this study was to systematically evaluate the quality of clinical guidelines on obstetric perineal trauma and care using the AGREE II instrument. We searched Medline, PubMed, Web of Science and ScienceDirect databases from inception until the 15th of December 2018 using the terms "guideline" OR "guidelines", OR "guidance", OR "recommendation" AND "obstetric anal sphincter injury", OR "perineal laceration" OR "perineal tear" OR "perineal trauma" OR "vaginal tear". Twelve guidelines were included, in English and Spanish.The assessment of the guidelines was performed using AGREE II by 5 appraisers.Ten guidelines scored more than 50 %, and 3 of them scored higher than 70 %. Two guidelines scored

Aims In the current climate of evidence‐based health care, the aim of this meta‐synthesis was to collect and systematically analyse data from primary qualitative studies on pelvic organ prolapse (POP), to identify patient‐centered perspectives on the natural course of POP. Information acquired in this study may be useful for ongoing research towards the development of core outcome sets (COS) in pelvic floor disorders. Methods A CHORUS Working Group performed a standardized search of three different databases (Medline, Embase, Scopus), from inception to October 2019. We selected qualitative studies on women's perspectives on POP that were published in the English language. Three reviewers independently evaluated the quality of eligible papers and highlighted recurrent themes based on patient perspectives. Results Eighteen qualitative studies including a total of 497 patients were assessed in this analysis. Our study revealed five superordinate themes, recurrently encountered in qualitative studies on POP: awareness of POP (6 studies), communication (9 studies), treatments (10 studies), effects on quality of life (6 studies), and self‐image (3 studies). Five out of 10 quality criteria were met by all the studies included, based on an assessment performed using the critical appraisal skills program. Conclusions This is the first synthesis of qualitative studies that address POP‐related experiences of women, highlighting five superordinate themes, of which treatment was the most commonly reported one. This synthesis' findings may guide quantitative research priorities and will hopefully contribute to the development of a COS for POP.

Supplemental Digital Content is available in the text, Introduction: Randomized trials evaluating interventions for stress urinary incontinence (SUI) have been using variable outcome measures, reporting a variety of outcomes. Alongside this variation across studies, outcome-reporting flaws contribute to a limited use of research to inform clinical practice. The development and use of core outcome sets (COSs) in future trials would ensure that outcomes important to different stakeholders and primarily women with SUI are reported more consistently and comprehensively. Methods: An international steering group including healthcare professionals, researchers, and women with urinary incontinence will guide the development of this COS. Potential outcomes will be identified through comprehensive literature reviews. These outcomes will be entered into an international, multiperspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and women with urinary incontinence, will be invited to participate. The modified Delphi method encourages stakeholder group convergence toward collective agreement, also referred as consensus, core outcomes. Discussion: Dissemination and implementation of the resulting COS within an international context will be promoted and reviewed. Embedding the COS for SUI within future clinical trials, systematic reviews and clinical practice guidelines could make a significant contribution to advancing the value of research in informing clinical practice, enhancing patient care and improving outcomes. The infrastructure created by developing a COS for SUI could be leveraged in other settings, for example, selecting research priorities and clinical practice guideline development.

The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life‐changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta‐analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. Aims We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. Methods Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. Results Seventy‐one randomized trials were included. Twenty‐four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. Conclusions Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium‐ and long‐term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues.

Background Evidence on efficacy and safety of pelvic organ prolapse interventions is variable, and methodological flaws preclude meaningful synthesis of primary research data. Objective To evaluate variations in reported outcomes and outcome measures in randomized controlled trials (RCTs) on apical prolapse surgical interventions. Search strategy We searched Cochrane, EMBASE, MEDLINE, and Scopus for English-language articles published from inception to September 30, 2017, using the terms "management", "repair", "operation", and "pelvic organ prolapse". Selection criteria RCTs on apical prolapse surgical treatment. Data collection and analysis Outcomes and outcome measures were identified and categorized into domains. Studies were evaluated for quality of outcomes. Descriptive statistics were used to calculate frequencies. Main results Forty-three RCTs were included. Seventy-six outcomes and 66 outcome measures were identified. Bladder and ureteric injury were the most commonly reported intraoperative complications (19/31 studies; 61%). Quality of life was assessed by 19 different instruments and questionnaires. Fourteen (45%) of 31 studies used recurrence of prolapse as a postoperative anatomical outcome. Conclusions Substantial variation in reported outcomes and outcome measures was confirmed, precluding comparisons across trials and synthesis of the results. Development of a core outcome set will enable high-quality meta-analyses to be performed in the future. PROSPERO registration: CRD42017062456.

Aim For four decades, the training for fellows in Urogynecology has been defined by taking into account the proposals of the relevant international societies. Primary health care providers and general OB/GYN practitioners could not find validated guidelines for the integration of knowledge in pelvic floor dysfunctions. The FIGO Working Group (FWG) in Pelvic Floor Medicine and Reconstructive Surgery has looked for the consensus of international opinion leaders in order to develop a set of minimal requirements of knowledge and skills in this area. Method This manuscript is divided into three categories of knowledge and skills, these are: to know, to understand, and to perform in order to offer the patients a more holistic health care in this area. Results The FWG reached consensus on the minimal requirements of knowledge and skills regarding each of the enabling objectives identified for postgraduate obstetrics and gynecology physicians and for residents in obstetrics and gynecology. Conclusions Our goal is to propose and validate the basic objectives of minimal knowledge in pelvic floor medicine and reconstructive surgery. Neurourol. Urodynam. © 2015 Wiley Periodicals, Inc.

In a prospective, observational study of antibiotic prophylaxis in gynecologic surgery, the efficacy of pefloxacin in preventing post-operative infections was tested in 178 patients (median age, 47 years) who were hospitalized to undergo abdominal or vaginal gynecologic surgery. Pefloxacin was administered in a single intravenous dose before the surgery in the absence of clinical symptoms, signs, and laboratory data consistent with an infectious etiology. The failure rate of pefloxacin after abdominal surgery was 6.9%, whereas for the vaginal route it was 5.3%. No statistically significant difference was found between the two surgical approaches when the outcome of antibiotic prophylaxis was compared. Failures were related to fever of unknown origin (2 patients), wound infection (3), subfascial abscess (1), and urinary tract infection (1) for abdominal surgery, and to vaginal cuff abscess (1), urinary tract infection (1), pelvic cellulitis (1), and asymptomatic bacteriuria (1) for vaginal surgery. No adverse effects were reported in patients after administration of pefloxacin. None of the patients reported postoperative infections 6 weeks after discharge from the hospital. The use of pefloxacin, a drug with a long half-life and particular efficacy in the urinary tract, appears to be a good choice in a gynecologic surgery because it reduces the incidence of bacteriuria, the principal cause of infectious complications after this type of surgery. These observational results should be confirmed by randomized, masked studies of antibiotic prophylaxis comparing pefloxacin with cephalosporins, semisynthetic penicillins, and other drugs in gynecologic surgery.

The objective was to evaluate in a homogeneous series of patients the clinical and urodynamic outcomes following anterior colporraphy and approximation of pubococcygeus muscles for correcting cystocele and genuine stress incontinence (SUI). The authors analyzed the pre- and postoperative clinical and urodynamic data of 56 consecutive, not previously operated, patients underwent anterior colporraphy and approximation of pubococcygeus muscles by the same surgeon. The mean follow-up period was 20 months (range 12–32). Statistical analysis was performed with Wilcoxon matched pairs test and Fisher’s exact test. Four (8%) patients experienced cystocele recurrence at a lesser degree than preoperatively and 2 (4%) patients developed grade II rectocele postoperatively. Recurrence of cystocele occurred only among those patients undergone sacrospinous colposuspension (4 out of 20 vs. 0 out of 32, P=0.018). Manifested and potential genuine stress incontinence (Pot-SUI) treatment was successful in 18 out of 30 (60%) patients. These patients showed a significant increase (P