Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy?

Phase 3

• Conditions: Urinary Incontinence
• Interventions: Procedure: Posterior reconstruction of the rhabdosphincter

• Registration Number: NCT01809522
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

The present study is a multicenter randomized, controlled trial, whose aim is to verify the effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical prostatectomy on early recovery of urinary continence.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-03
• Study First Submitted: 2013-03-09
• Study First Submitted QC: 2013-03-09
• Study First Posted: 2013-03-12
• Last Update Submitted: 2013-03-12
• Last Update Posted: 2013-03-13
• Primary Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 1500

Inclusion Criteria

• Age ≥18 and ≤ 80 years;
• Biopsy proven clinically localized prostate cancer;
• Informed consent obtained and signed;
• Understanding of, and willingness to comply with, the study procedures.

Exclusion Criteria

• Pre-operative incontinence;
• Salvage prostatectomy (defined as a prostatectomy prescribed after the failure of a different primary treatment);
• Surgical posterior plane at the peri - rectal fat, without preserving an edge of the Denonvilliers;
• History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterior reconstruction of the musculofascial plate	Posterior reconstruction of the rhabdosphincter	These patients will receive reconstruction of the muscolofascial plate after radical prostatectomy. The reconstruction will be performed using two 3-0 Poliglecaprone sutures (on RB-1 needles) tied together, with each individual length being 12-15 cm. seven - Ten knots will be placed when tying the sutures to provide a bolster. The free edge of the remaining Denonvillier's fascia will be identified after the prostatectomy and approximated to the posterior aspect of the rhabdosphincter and the posterior median raphe using one arm of the continuous suture. As a rule, four passes will be taken from the right to the left and the suture is locked. The second layer of the reconstruction will be then performed with the other arm of the suture approximating the posterior lip of the bladder neck (full thickness) and the vesicoprostatic muscle to the posterior urethral edge and to the already reconstructed median raphe .This suture will be then tied to the end of the first suture arm.

Primary Outcome Measures

Name	Time	Method
Urinary continence	12 months	No urinary leakages, assessed with the EPIC Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Sexual potency	12 months	Potency sufficient for intercourse, with or without use of PDE5i, assessed with the IIEF Questionnaire.
Oncologic radicality	12 months	PSA \< 0,2 ng/ml.

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy