I-STOP TOMS - Trans Obturator Male Sling - Full Text View

Sponsored by:	CL Medical
Information provided by:	CL Medical
ClinicalTrials.gov Identifier:	NCT00442078

Purpose

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.

Condition	Intervention	Phase
Male Urinary Incontinence	Device: I-STOP TOMS Device: Transobturator male sling	Phase IV

MedlinePlus related topics: Urinary Incontinence Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by CL Medical:

Primary Outcome Measures:

Primary criteria:
Total continence or improved continence on determined time of follow-up, with questionnaires and PAD test.:
 Success: full clinical efficiency on incontinence and improvement of the quality of life.
 Improvement: partial result on clinical efficiency or QOL.
 Failure: no clinical efficiency compare to the pre-operative stage.

Secondary Outcome Measures:

Secondary criteria:
 Number of PAD for 24 hours: question 3 / SF 36 – UCLA PCI urinary function score
 Incontinence score SF 36 : questions 1 + 2 / SF 36 – UCLA PCI urinary function score
 Incontinence score ICIQ : questions 1 + 2 + 4 / ICIQ
 Urinary score SF 36 : question 4 + 5 / SF 36 – UCLA PCI urinary function score
 Urinary score ICIQ : question 3 / ICIQ
 PAD test
 Satisfaction rate

Estimated Enrollment:	50
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2008

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 Tél. : + 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 Tél. : + 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 : 6 months
Follow-up : 12 months
Total : 18 months

Key words

Incontinence
Urinary
Male
Tape
Transobturator

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442078

Contacts

Contact: Philippe GRISE, Professor

(+33) (0) 2.32.88.81.73

Philippe.Grise@chu-rouen.fr

Locations

France
Rouen University Hospital	Recruiting
Rouen, France, 76000
Contact: Philippe Grise, Professor (+33) (0) 2.32.88.81.73 Philippe.Grise@chu-rouen.fr

Sponsors and Collaborators

CL Medical

Investigators

Principal Investigator:

Philippe GRISE, Professor

Rouen University Hospital - France

More Information

Study ID Numbers:	020402
Study First Received:	February 27, 2007
Last Updated:	February 28, 2007
ClinicalTrials.gov Identifier:	NCT00442078
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by CL Medical:

Incontinence
Urinary
Male
Tape
Transobturator

Study placed in the following topic categories:

Signs and Symptoms
Urologic Diseases
Urination Disorders
Quality of Life
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009