Back to resultsDoes Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy? (PRR)
Primary Purpose
Urinary Incontinence
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Posterior reconstruction of the rhabdosphincter
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Robotic-assisted radical prostatectomy, Urinary continence, Posterior reconstruction of the rhabdosphincter, Posterior musculofascial plate reconstruction
Eligibility 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;
Sites / Locations
- Fondazione IRCCS Ca' Granda - Ospedale Maggiore PoliclinicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Posterior reconstruction of the musculofascial plate
Standard radical prostectomy
Arm Description
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.
Outcomes
Primary Outcome Measures
Urinary continence
No urinary leakages, assessed with the EPIC Questionnaire.
Secondary Outcome Measures
Oncologic radicality
PSA < 0,2 ng/ml.
Sexual potency
Potency sufficient for intercourse, with or without use of PDE5i, assessed with the IIEF Questionnaire.
Full Information
NCT ID
NCT01809522
First Posted
March 9, 2013
Last Updated
March 12, 2013
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT01809522
Brief Title
Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy?
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Robotic-assisted radical prostatectomy, Urinary continence, Posterior reconstruction of the rhabdosphincter, Posterior musculofascial plate reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Posterior reconstruction of the musculofascial plate
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard radical prostectomy
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Posterior reconstruction of the rhabdosphincter
Primary Outcome Measure Information:
Title
Urinary continence
Description
No urinary leakages, assessed with the EPIC Questionnaire.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Oncologic radicality
Description
PSA < 0,2 ng/ml.
Time Frame
12 months
Title
Sexual potency
Description
Potency sufficient for intercourse, with or without use of PDE5i, assessed with the IIEF Questionnaire.
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernardo Rocco, MD
Phone
+390255034549
Email
bernardo.rocco@gmail.com
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernardo Rocco, MD
Phone
+390255034549
Email
bernardo.rocco@gmail.com
First Name & Middle Initial & Last Name & Degree
Bernardo Rocco, MD
12. IPD Sharing Statement
Learn more about this trial
Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy?
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