Urinary Incontinence Clinical Trial
— PRROfficial 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.
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility |
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; |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico | Milano |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary continence | No urinary leakages, assessed with the EPIC Questionnaire. | 12 months | No |
Secondary | Oncologic radicality | PSA < 0,2 ng/ml. | 12 months | No |
Secondary | Sexual potency | Potency sufficient for intercourse, with or without use of PDE5i, assessed with the IIEF Questionnaire. | 12 months | No |
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