I-STOP TOMS - Trans Obturator Male Sling
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Evaluation of continence and QoL with questionnaires and PAD test [ Time Frame: 1 month, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]
- UCLA SF36 score and ICIQ continence [ Time Frame: 1-3-6-12 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Device: I-STOP TOMS male sling
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.
Pr. Philippe GRISE - Professor and Chairman of Urology Hopital Charles Nicolle, 1 rue de Germont, 76000 Rouen-FRANCE Tel+ 33.(0)126.96.36.199.73 Fax+ 33.(0)188.8.131.52.05 Email email@example.com
Promoter Vincent GORIA - CEO CL Médical, 28, avenue Général de Gaulle, 69110 Sainte Foy Les Lyon - FRANCE Tel+33.(0)184.108.40.206.93 Fax+33.(0)220.127.116.11.78 Email firstname.lastname@example.org
Forty urologist surgeons are involved on this study.
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442078
|Rouen University Hospital|
|Rouen, France, 76000|
|Principal Investigator:||Philippe GRISE, Professor||Rouen University Hospital - France|