No abstract

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.

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 <50 % and were considered as low quality. Level of evidence and grade of recommendations were used by 7 guidelines of the 12 guidelines. Although some guidelines received high scores, there is space for improvement of the standards of guidelines.

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.

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 (b = 0.538, P < 0.001; b = 0.218, P = 0.011, respectively).Conclusions Outcome reporting in SUI trials is highly variable. Until a core outcome set is developed and implemented, we propose an interim use of three commonly reported outcomes in each domain (treatment success ratecomplete cure, partial improvement, or failure of response; urodynamic evaluation outcomesoveractive bladder (OAB), voiding dysfunction, and urodynamic stress incontinence; patient-reported outcomesquality of life, sexual dysfunction, and patient satisfaction) with the use of validated questionnaires for patient-reported outcomes and subjective success rates. Complications should be also explicitly and comprehensively reported using validated outcome measures.