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A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)

NCT00196521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2007-12-13

No results posted yet for this study

Summary

Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients in the study will have an operation to improve urinary incontinence symptoms. This will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). During the operation, the study doctor will use tension-free vaginal obturator system. The study will include women diagnosed with Stress Urinary Incontinence who have completed their families.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Tension-free vaginal tape obturator system

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Weisberg, MD · Ethicon, Inc.

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Completion
2007-03-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Singapore
  • South Korea
  • United Kingdom

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 NCT00196521 on ClinicalTrials.gov