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CompletedNCT00442078Updated Sep 11, 2012

I-STOP TOMS - Trans Obturator Male Sling

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

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Sex
Male
01

Study summary

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.

Read the 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

02

Conditions studied

  • Male Urinary Incontinence

Keywords

  • Incontinence
  • Urinary
  • Male
  • Tape
  • Transobturator
03

In context

Urinary Incontinence

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 →

Lead sponsor

This is the only study on the registry with CL Medical as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Interventions

  • DeviceI-STOP TOMS male sling

    Bulbus urethral compression with polypropylene mesh

06

What researchers measure

Primary outcomes

  1. Evaluation of continence and QoL with questionnaires and PAD test

    Time frame: 1 month, 3 months, 6 months, 12 months

Secondary outcomes

  1. UCLA SF36 score and ICIQ continence

    Time frame: 1-3-6-12 months

07

Study locations

1 site
  • Rouen University Hospital
    Rouen, 76000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00442078
Lead sponsor
CL Medical
Responsible party
Sponsor
First posted
Mar 1, 2007
Start date
May 2006
Primary completion
May 2007
Completion
Jun 2009
Last update
Sep 11, 2012

Study contacts

Philippe GRISE, Professor
principal investigator · Rouen University Hospital - France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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