I-STOP TOMS - Trans Obturator Male Sling
I-STOP TOMS - Trans Obturator Male Sling
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
Inclusion Criteria:

 -  Male, with post-prostatectomy urinary incontinence (either after radical prostatectomy
 or prostatectomy of prostate adenoma, whatever the route used), and for whom there has
 been more than 6 months follow-up since the date of that procedure.

 -  The patient should have been proposed urinary re-education, which was refused for
 personal reasons, or should still suffer from urinary incontinence despite the
 re-education.

 -  Urinary incontinence is materialized in this population by a score between 4 and 16
 (inclusive) for the three questions of the ICIQ questionnaire.

 -  A urodynamic assessment including flow measurement and residue will have been carried
 out.

 -  A urethroscopy or urethrography will have been carried out to eliminate cases of
 urethral stenosis.

 -  Inclusion is subject to obtaining informed written consent, after remittance of the
 information sheet, and having had a detailed medical examination carried out.

 -  Medication for urinary incontinence and in particular anticholinergic drugs must have
 been stopped at least 15 days prior to initial assessment and for the duration of the
 trial. The same goes for urinary re-education.

 Exclusion Criteria:

 -  Progressing prostatic neoplasia materialized by testing of PSA levels.

 -  Prostate radiotherapy.

 -  Neurological disorder which might lead to urinary incontinence or hinder assessment.

 -  Urethral or anastomotic stenosis materialized by urethroscopy or urethrography.

 -  Hyperactive detrusor muscle with leakage contemporaneous with uninhibited
 contractility.

 -  Chronic retention of urine with leakage due to overflow.

 -  Current urinary infection. This would be a temporary exclusion since assessment can
 take place after treatment and monitoring for sterility of urine.