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Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence

NCT00534365 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2017-06-09

Study results available
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Summary

The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

tension-free vaginal tape

Retropubic mid-urethral sling

DEVICE

TVT-SECUR device

Mid-urethral mini-sling

Sponsors & Collaborators

  • Good Samaritan Hospital, Ohio

    collaborator OTHER

  • Greater Baltimore Medical Center

    collaborator OTHER

  • Medstar Health Research Institute

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • Foundation for Female Health Awareness

    collaborator OTHER

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Main Line Health

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00534365 on ClinicalTrials.gov