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Study Comparing Tension-free Vaginal Tape With the Monarc Procedure for Stress Urinary Incontinence

NCT00475839 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2013-01-10

No results posted yet for this study

Summary

Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Many different surgical procedures have been described for the treatment of SUI and there is no general agreement as to the most effective. This study compares the safety and efficacy of the tension-free vaginal tape procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary incontinence.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Tension-free Vaginal Tape

DEVICE

Monarc sub-fascial hammock

Sponsors & Collaborators

  • Good Samaritan Hospital, Ohio

    collaborator OTHER

  • Greater Baltimore Medical Center

    collaborator OTHER

  • American Medical Systems

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Matthew D Barber, MD, MHS · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Completion
2007-07-31

Countries

  • United States

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 NCT00475839 on ClinicalTrials.gov