Protocol for a systematic review and meta-analysis on preoperative risk factors for failure after fixed sling implantation for post-prostatectomy stress urinary incontinence

Abstract

Background: Post-prostatectomy urinary incontinence (PPI) is a bothersome complication affecting patients undergoing prostate surgery that in up 10% of cases will require an invasive treatment with fixed slings or artificial urinary sphincters (AUS). Although fixed slings have several advantages over AUS, failure rates after slings range between 15% and 45% while current knowledge of predictors of sling efficacy remains limited. By systematically combining and summarizing all relevant literature, the present review and meta-analysis aim to address this research need assessing the association between preoperative risk factors and sling failure. Methods: Studies pertaining to fixed synthetic male perineal slings as treatment for adult male suffering from PPI, will be included. A systematic search will be conducted in PubMED, Scopus, Web of Science and Cochrane databases, and in the reference lists of retrieved articles. Independent reviewers will conduct study selection and data extraction. Outcomes will include failure to achieve the continence cure and overall success (cure plus improvement), measured as per included studies. Exposures will include any preoperative variables evaluated for association with sling failure. The QUIPS tool will be used for study quality assessment and a random-effects DerSimonian-Laird model, with Hartung-Knapp adjustment, will be used to pool adjusted and unadjusted odds ratios separately. Sensitivity analysis will be performed using the leave-one-out methodology and subgroup meta-analyses based on pre-specified studies’ characteristics will be conducted to explain the heterogeneity. Certainty of evidence will be assessed according to GRADE methodology and review reporting will comply with the PRISMA-P statement. Discussion: By summarising all relevant literature in the field, our results will help to incorporate available evidence into clinical practice assisting healthcare professionals managing PPI patients in treatment decision-making. The present review will also provide researchers with the necessary, evidence-based groundwork to perform future high-quality prognostic studies in the field. Registration: CRD42022307160.