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

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ClinicalTrials.gov Identifier: NCT01809522
Recruitment Status : Unknown
Verified March 2013 by Bernardo Rocco, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was:  Recruiting
First Posted : March 12, 2013
Last Update Posted : March 13, 2013
Sponsor:
Information provided by (Responsible Party):
Bernardo Rocco, 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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Procedure: Posterior reconstruction of the rhabdosphincter Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : January 2013
Estimated Primary Completion Date : March 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Urinary continence [ Time Frame: 12 months ]
    No urinary leakages, assessed with the EPIC Questionnaire.


Secondary Outcome Measures :
  1. Oncologic radicality [ Time Frame: 12 months ]
    PSA < 0,2 ng/ml.

  2. Sexual potency [ Time Frame: 12 months ]
    Potency sufficient for intercourse, with or without use of PDE5i, assessed with the IIEF Questionnaire.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809522


Contacts
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Contact: Bernardo Rocco, MD +390255034549 bernardo.rocco@gmail.com

Locations
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Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20014
Contact: Bernardo Rocco, MD    +390255034549    bernardo.rocco@gmail.com   
Principal Investigator: Bernardo Rocco, MD         
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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Responsible Party: Bernardo Rocco, Principal Investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01809522     History of Changes
Other Study ID Numbers: Posterior Reconstruction
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013

Keywords provided by Bernardo Rocco, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Robotic-assisted radical prostatectomy
Urinary continence
Posterior reconstruction of the rhabdosphincter
Posterior musculofascial plate reconstruction

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders