Suspended

PRRDoes 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.

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What is being tested

Posterior reconstruction of the rhabdosphincter

Procedure
Who is being recruted

Urogenital Diseases+8

+ Female Urogenital Diseases and Pregnancy Complications

+ Signs and Symptoms

From 18 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study ContactBernardo Rocco, MDMore contacts
Last updated: March 13, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study ContactBernardo Rocco, MDMore contacts
Last updated: March 13, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesUrological ManifestationsFemale Urogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrinary Incontinence

Criteria

4 inclusion criteria required to participate
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

4 exclusion criteria prevent from participating
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

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

No Intervention

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, ItalyOpen Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico in Google Maps
SuspendedOne Study Center