A systematic review on outcome reporting in randomized controlled trials on surgical interventions for female stress urinary incontinence. A call to develop a core outcome set.

Several meta-analyses have identified methodological limitations in female stress urinary incontinence (SUI) trials, precluding synthesis of primary studies and high-quality evidence.Evaluation of outcome measure selection and outcome reporting in randomised controlled trials (RCTs) on surgery for SUI.Systematic review of RCTs identified from bibliographical databases including Medline, Cochrane and EMBASE.RCTs evaluating the efficacy and safety of surgical interventions for the management of female SUI.Two researchers independently assessed the included studies and documented outcomes.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 was 3 (range 0-3) and outcome reporting quality 3 (range 0-5). Multinomial logistic regression analysis revealed that the methodological quality and use of validated questionnaire were significant predictors of outcome reporting quality. (β=0.538; p<.001, β=0.218; p=.011, respectively).Outcome reporting in SUI trials is highly variable Until a core outcome set is developed and implemented, we propose an interim use of 3 commonly reported outcomes in each domain (treatment success rate: complete cure, partial improvement, failure of response; urodynamic evaluation outcomes: OAB, voiding dysfunction, urodynamic stress incontinence; patient-reported outcomes: quality of life, sexual dysfunction, patient satisfaction) with use of validated questionnaires for patient reported outcomes and subjective success rates. Complications should be also explicitly and comprehensively reported using validated outcome measures. This article is protected by copyright. All rights reserved.