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
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Procedure: Posterior reconstruction of the rhabdosphincter||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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|
- Urinary continence [ Time Frame: 12 months ]No urinary leakages, assessed with the EPIC Questionnaire.
- Oncologic radicality [ Time Frame: 12 months ]PSA < 0,2 ng/ml.
- Sexual potency [ Time Frame: 12 months ]Potency sufficient for intercourse, with or without use of PDE5i, assessed with the IIEF Questionnaire.
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
|Contact: Bernardo Rocco, MDfirstname.lastname@example.org|
|Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico||Recruiting|
|Milano, Italy, 20014|
|Contact: Bernardo Rocco, MD +390255034549 email@example.com|
|Principal Investigator: Bernardo Rocco, MD|