A Phase 3 interventional study of Posterior reconstruction of the rhabdosphincter in Urinary Incontinence, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Status unknown at 1 site in Italy. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-03-13.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Phase 3, Interventional, and Treatment
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Urinary continence
No urinary leakages, assessed with the EPIC Questionnaire.
Time frame: 12 months
Oncologic radicality
PSA \< 0,2 ng/ml.
Time frame: 12 months
Sexual potency
Potency sufficient for intercourse, with or without use of PDE5i, assessed with the IIEF Questionnaire.
Time frame: 12 months
This study is status unknown, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico