Back to resultsI-STOP TOMS - Trans Obturator Male Sling
Primary Purpose
Male Urinary Incontinence
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
I-STOP TOMS male sling
Sponsored by
About this trial
This is an interventional treatment trial for Male Urinary Incontinence focused on measuring Incontinence, Urinary, Male, Tape, Transobturator
Eligibility 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.
Sites / Locations
- Rouen University Hospital
Outcomes
Primary Outcome Measures
Evaluation of continence and QoL with questionnaires and PAD test
Secondary Outcome Measures
UCLA SF36 score and ICIQ continence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00442078
Brief Title
I-STOP TOMS - Trans Obturator Male Sling
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CL Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Urinary Incontinence
Keywords
Incontinence, Urinary, Male, Tape, Transobturator
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
I-STOP TOMS male sling
Intervention Description
Bulbus urethral compression with polypropylene mesh
Primary Outcome Measure Information:
Title
Evaluation of continence and QoL with questionnaires and PAD test
Time Frame
1 month, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
UCLA SF36 score and ICIQ continence
Time Frame
1-3-6-12 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe GRISE, Professor
Organizational Affiliation
Rouen University Hospital - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
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I-STOP TOMS - Trans Obturator Male Sling
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