I-STOP TOMS - Trans Obturator 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.

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.

Study Overview

• Status: Completed
• Conditions: Male Urinary Incontinence
• Intervention / Treatment: Device: I-STOP TOMS male sling

Detailed Description

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
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of continence and QoL with questionnaires and PAD test	1 month, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
UCLA SF36 score and ICIQ continence	1-3-6-12 months

Collaborators and Investigators

• Sponsor: CL Medical
• Investigators: Principal Investigator: Philippe GRISE, Professor, Rouen University Hospital - France

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: February 27, 2007
• First Submitted That Met QC Criteria: February 28, 2007
• First Posted (Estimate): March 1, 2007

Study Record Updates

• Last Update Posted (Estimate): September 11, 2012
• Last Update Submitted That Met QC Criteria: September 8, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Incontinence; Male; Urinary; Tape; Transobturator
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: 020402