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TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

NCT00676273 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2008-05-13

No results posted yet for this study

Summary

The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and clinical efficacy in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

TVT-Obturator (TVT-O)

sub urethral sling

DEVICE

TVT-Secur (TVT-S) (Hammock method)

suburethral sling

Sponsors & Collaborators

  • Boston Urogynecology Associates

    lead OTHER

Principal Investigators

  • Peter Rosenblatt, MD · Boston Urogynecology Associates

  • Lekha Hota, MD · Boston Urogynecology Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-03-31
Completion
2009-12-31

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 NCT00676273 on ClinicalTrials.gov