Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442078
Status:
COMPLETED
Last Update Posted:
2012-09-11
First Post:
2007-02-27
Brief Title:
I-STOP TOMS - Trans Obturator Male Sling
Sponsor:
CL Medical
Organization:
CL Medical
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 330232888173 Fax 330232888205 Email philippegrisechu-rouenfr
Promoter Vincent GORIA - CEO CL Médical 28 avenue Général de Gaulle 69110 Sainte Foy Les Lyon - FRANCE Tel330478595493 Fax330478598978 Email vgoriaclmedicalcom
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
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 330232888173 Fax 330232888205 Email philippegrisechu-rouenfr
Promoter Vincent GORIA - CEO CL Médical 28 avenue Général de Gaulle 69110 Sainte Foy Les Lyon - FRANCE Tel330478595493 Fax330478598978 Email vgoriaclmedicalcom
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None