Male Urinary Incontinence Clinical Trial
Official title:
Evaluation of the Efficacy on Urinary Continence and Quality of Life of the Sub-urethral Tape I-STOP® Using the Transobturator and Perineal Route on Male Incontinent After Radical Prostatectomy.
The main objective is to evaluate the clinical efficacy on continence, quality of life and tolerance of the sub-urethral tape I-STOP on male patient suffering of incontinence significant and embarrassing after a radical prostatectomy.
Title
Evaluation of the efficacy on urinary continence and quality of life of the sub-urethral
tape I-STOP using the transobturator and perineal route on male incontinent after radical
prostatectomy.
Chief Investigator:
Pr. Philippe GRISE - Professor and Chairman of Urology Hopital Charles Nicolle, 1 rue de
Germont, 76000 Rouen-FRANCE Tel+ 33.(0)2.32.88.81.73 Fax+ 33.(0)2.32.88.82.05 Email
philippe.grise@chu-rouen.fr
Promoter Vincent GORIA - CEO CL Médical, 28, avenue Général de Gaulle, 69110 Sainte Foy Les
Lyon - FRANCE Tel+33.(0)4.78.59.54.93 Fax+33.(0)4.78.59.89.78 Email vgoria@clmedical.com
Associate investigators
Forty urologist surgeons are involved on this study.
Objective
The main objective is to evaluate the clinical efficacy on continence, quality of life and
tolerance of the sub-urethral tape I-STOP on male patient suffering of incontinence
significant and embarrassing after a radical prostatectomy.
Methodology
Opened study, prospective, multicenter, with direct individual benefit.
Number of patients
50 patient minimum, with 1 to 3 patients for each investigator.
Duration Including: 12 months Follow-up: 12 months Total: 24 months
Key words Incontinence Urinary Male Tape Transobturator
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment