A Phase 4 interventional study of I-STOP TOMS male sling in Male Urinary Incontinence, sponsored by CL Medical. Completed at 1 site in France. Open to male participants. Per ClinicalTrials.gov, last updated 2012-09-11.
Sponsored by CL Medical · Phase 4, Interventional, and Treatment
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
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 50 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →This is the only study on the registry with CL Medical as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bulbus urethral compression with polypropylene mesh
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
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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