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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Bulbus urethral compression with polypropylene mesh
Rouen University Hospital
Rouen, France
Evaluation of continence and QoL with questionnaires and PAD test
Time frame: 1 month, 3 months, 6 months, 12 months
UCLA SF36 score and ICIQ continence
Time frame: 1-3-6-12 months
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