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

Does the Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy? A Multicenter Randomized Controlled Trial. A Phase III Open-label Prospective International Multicenter Randomized Controlled Study for the Evaluation of the Efficacy of PRR, in Patients Subjected to RALP, Measured in Terms of Early Recovery of the Continence.

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Incontinence
• Intervention / Treatment: Procedure: Posterior reconstruction of the rhabdosphincter

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20014
    • Recruiting
    • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
    • Contact: Bernardo Rocco, MD; Phone Number: +390255034549; Email: bernardo.rocco@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Posterior reconstruction of the musculofascial plate; 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.	Procedure: Posterior reconstruction of the rhabdosphincter
NO_INTERVENTION: Standard radical prostectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary continence	No urinary leakages, assessed with the EPIC Questionnaire.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ANTICIPATED): March 1, 2015

Study Registration Dates

• First Submitted: March 9, 2013
• First Submitted That Met QC Criteria: March 9, 2013
• First Posted (ESTIMATE): March 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 13, 2013
• Last Update Submitted That Met QC Criteria: March 12, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Urinary continence; Robotic-assisted radical prostatectomy; Posterior reconstruction of the rhabdosphincter; Posterior musculofascial plate reconstruction
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: Posterior Reconstruction