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I-STOP TOMS - Trans Obturator Male Sling

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CL Medical
ClinicalTrials.gov Identifier:
NCT00442078
First received: February 27, 2007
Last updated: September 8, 2012
Last verified: September 2012
History of Changes
  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 male sling
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CL Medical:

Primary Outcome Measures:
  • Evaluation of continence and QoL with questionnaires and PAD test [ Time Frame: 1 month, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • UCLA SF36 score and ICIQ continence [ Time Frame: 1-3-6-12 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2006
Study Completion Date: June 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: I-STOP TOMS male sling
    Bulbus urethral compression with polypropylene mesh
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

  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

Locations
France
Rouen University Hospital
Rouen, France, 76000
Sponsors and Collaborators
CL Medical
Investigators
Principal Investigator: Philippe GRISE, Professor Rouen University Hospital - France
  More Information

No publications provided

Responsible Party: CL Medical
ClinicalTrials.gov Identifier: NCT00442078     History of Changes
Other Study ID Numbers: 020402
Study First Received: February 27, 2007
Last Updated: September 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by CL Medical:
Incontinence
Urinary
Male
Tape
Transobturator

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013