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I-STOP TOMS - Trans Obturator Male Sling

NCT00442078 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-09-11

No results posted yet for this 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.

Conditions

  • Male Urinary Incontinence

Interventions

DEVICE

I-STOP TOMS male sling

Bulbus urethral compression with polypropylene mesh

Sponsors & Collaborators

  • CL Medical

    lead INDUSTRY

Principal Investigators

  • Philippe GRISE, Professor · Rouen University Hospital - France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-05-31
Completion
2009-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442078 on ClinicalTrials.gov