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

Urinary Incontinence Clinical Trial

— PRR  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01809522
• Other study ID #: Posterior Reconstruction
• Status: Recruiting
• Phase: Phase 3
• First received: March 9, 2013
• Last updated: March 12, 2013
• Start date: January 2013

Study information

• Verified date: March 2013
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Bernardo Rocco, MD
• Phone: +390255034549
• Email: bernardo.rocco[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Regione Lombardy. Ethics Commitee for clinical experimentation of Drugs. Via Pola 9/11 20124 Milan, Italy.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Procedure:
• Posterior reconstruction of the rhabdosphincter

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary continence	No urinary leakages, assessed with the EPIC Questionnaire.	12 months	No
Secondary	Oncologic radicality	PSA < 0,2 ng/ml.	12 months	No
Secondary	Sexual potency	Potency sufficient for intercourse, with or without use of PDE5i, assessed with the IIEF Questionnaire.	12 months	No