A Pilot Randomized Trial of Preoperative Pelvic Floor Muscle Exercise versus Usual Care to Treat Urinary Incontinence after Robotic-Assisted Radical Prostatectomuy (RARP): A Study Protocol

Maria Angela Cerruto, Marco Sebben, Marco Pirozzi, Matteo Balzarro, Antonio Porcaro and Walter Artibani

Department of Surgery, Dentistry Paediatrics and Gynaecology, University of Verona, Italy

^*Correspondance to: Maria Angela Cerruto 

 PDF  Full Text DOI: 10.25107/2474-1647.1488

Abstract

Background: Radical prostatectomy represents the most common and effective treatment for localised prostate cancer. Recently, robot-assisted radical prostatectomy (RARP) has become increasingly used worldwide. Although a recent systematic review and meta-analysis found that RARP had higher postoperative continence rates than retropubic or laparoscopic radical prostatectomy, urinary incontinence (UI) and sexual dysfunction remain the most bothersome postoperative complications even after RARP. Pelvic floor muscle training (PFMT) may represent a valid treatment to improve postoperative urinary continence as well as sexual function. The aim of this study will be to carry out a randomised controlled trial in order to determine a causal relationship between preoperative PFMT and postoperative functional outcomes in patients undergoing RARP.Methods/
Design: This is a double-arm, single-centre, pilot randomized control trial conducted at an academic teaching hospital; at least 100 men undergoing RARP for prostate cancer with no contraindications to PFMT will be recruited and randomized to a pre-and post-operative PFMT program or usual care. PFMT participants will engage in a PFMT program. The PFMT prescription will begin with instructions on how to engage the pelvic floor delivered by the research coordinator trained in PFMT. Usual care participants will not receive any formal training in PFMT neither preoperatively nor after surgery. Estimates of intervention efficacy will be captured through measurements at baseline (4–8 weeks preoperatively), within 1 week prior to surgery, and postoperatively at 4, 12, and 26 weeks. UI will be assessed using the 24-h pad test, a 3-day, bladder diary. The ICIQ-Urinary Incontinence (ICIQ-UI) will be administered as an additional self-reported measure of Post-RARP UI. Quality of life (QoL) will be measured using the following widely used and psychometrically valid and reliable measures, validated in Italian language: The UCLA-PCI and the Short-Form 36 (SF-36). Additional urological symptoms will be assessed using the valid and reliable, 7-item International Prostate Symptom Score (IPSS) with its further item on QoL. Erectile function will be assessed using the 5-item International Index of Erectile Function (IIEF) scale.Discussion: The primary outcome of this study will be to examine a structured pre-, peri-, and post-surgical exercise program of PFMT for men undergoing RARP for prostate cancer. This trial will advance our understanding of strategies aiming at an early recovery of continence and sexual activity after RARP, and to efficiently and effectively use the pre-and peri-operative period to optimize post-operative continence and sexual recovery, improving patients’ QoL.

Keywords

Prostate cancer; RARP; PFMT; Randomized controlled trial; Rehabilitation

Cite the article

Cerruto MA, Sebben M, Pirozzi M, Balzarro M, Porcaro A, Artibani W. A Pilot Randomized Trial of Preoperative Pelvic Floor Muscle Exercise versus Usual Care to Treat Urinary Incontinence after Robotic-Assisted Radical Prostatectomuy (RARP): A Study Protocol. Clin Surg. 2017; 2: 1488.