I-STOP TOMS - Trans Obturator Male Sling
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|ClinicalTrials.gov Identifier: NCT00442078|
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : September 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Male Urinary Incontinence||Device: I-STOP TOMS male sling||Phase 4|
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)188.8.131.52.73 Fax+ 33.(0)184.108.40.206.05 Email firstname.lastname@example.org
Promoter Vincent GORIA - CEO CL Médical, 28, avenue Général de Gaulle, 69110 Sainte Foy Les Lyon - FRANCE Tel+33.(0)220.127.116.11.93 Fax+33.(0)18.104.22.168.78 Email email@example.com
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||June 2009|
Device: I-STOP TOMS male sling
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442078
|Rouen University Hospital|
|Rouen, France, 76000|
|Principal Investigator:||Philippe GRISE, Professor||Rouen University Hospital - France|