Status:
UNKNOWN
Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy?
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Urinary Incontinence
Eligibility:
MALE
18-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT01809522
Start Date
January 1 2013
Last Update
March 13 2013
Active Locations (1)
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1
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, Italy, 20014