Protocol for the RoboSling Trial: A Randomised Study Assessing Urinary Continence Following Robotic Radical Prostatectomy with or without an Intraoperative Retropubic Vascularised Fascial Sling (RoboSling)

Abstract

Objectives: To determine if early (three months) and late (one year) post-operative continence is improved by performing a novel retropubic vascularised fascial sling (RoboSling) procedure concurrently with robot-assisted radical prostatectomy in men undergoing treatment for localised prostate cancer. To additionally assess surgical outcomes, quality of life and health economic outcomes in patients undergoing the novel RoboSling technique. Methods: This study aims to recruit 120 consecutive patients with clinically localised prostate cancer who have chosen to undergo robot-assisted radical prostatectomy in the Sydney Local Health District, Australia. A prospective assessment of early and late post-operative continence following robot-assisted radical prostatectomy with and without a RoboSling procedure will be performed in a two-group, 1:1, parallel, randomized controlled trial. Four surgeons will take part in the study, all of whom are beyond their learning curve. Patients will be blinded as to whether the RoboSling procedure is performed for them, as will be the research officers collecting the post-operative data on urinary function. Trial Registration: ACTRN12618002058257. Results: The trial is currently underway. Conclusions: The RoboSling technique is unique in that the sling is vascularised and has a broad surface area compared to previously described slings in the literature. If a clinically significant improvement in post-operative continence is established with the RoboSling, then, we can in turn expect improvements in quality of life for men undergoing this technique with radical prostatectomy.