Evaluation of benefits and harms of surgical treatments for post-radical prostatectomy urinary incontinence: a systematic review and meta-analysis protocol

Background: Post-radical prostatectomy urinary incontinence (PPI) is a frequent and feared complication that can affect approximately 25% of patients. Between 1 and 10% of patients suffering from PPI will require surgery. The effectiveness of the available surgical interventions has only been compared in a few randomized controlled trials and the available reviews have important limitations regarding both benefits and harms that make them insufficient to inform decision-making. The aim of the study is to provide systematic summaries of benefits and harms of contemporary surgical treatment options for PPI through systematic review and meta-analysis using GRADE methodology and reporting in accord with the PRISMA-P statement. Methods: Studies pertaining to bulking agents, male synthetic slings, compressive balloon systems (ProACT) or artificial urinary sphincters (AUS) used for the treatment of patients suffering from PPI will be included. A systematic search will be conducted using the OVID and PubMED platforms in MEDLINE, Embase and Cochrane databases, and reference lists of relevant reviews and guidelines. Trained independent reviewers will conduct study selection and data extraction. Outcomes will include the number of pads used per day, the 24-h pad weight test, the Patient Global Impression of Improvement (PGI-I) and the Incontinence Quality of Life (IQOL) as possible benefits and the reoperations, the Clavien-Dindo complications and the other reported adverse events as the harms. When possible, pooled analyses will be completed. Risk of bias will be assessed using the CLARITY tools and a new tool for the before-and-after studies without a control group. Finally, study heterogeneity will be assessed, publication bias will be evaluated with funnel plots and quality of evidence rated for each outcome. Discussion: Our study will address patient-important outcomes and will be useful in clinical decision-making as well as identifying key elements for future research. Study registration: PROSPERO: CRD42018073923 05/12/2018.