CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 281 enrolled
Drug / intervention
tension-free vaginal tape +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00534365
NCT00534365Phase 3Completed
CompareCT.gov

A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence

The Cleveland Clinic·interventional·Posted Sep 24, 2007·Updated Jun 9, 2017

In Brief

A Phase 3 clinical trial evaluating tension-free vaginal tape and TVT-SECUR device for Stress Urinary Incontinence. Completed, enrolled 281 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence
CountriesUnited States
CollaboratorsGood Samaritan Hospital, Ohio, Greater Baltimore Medical Center, Medstar Health Research Institute, Duke University, Foundation for Female Health Awareness, Women and Infants Hospital of Rhode Island, Main Line Health

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2007
Enrollment StartAug 1, 2007
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.8 years ago

Interventions

tension-free vaginal tapedevice

Retropubic mid-urethral sling

TVT-SECUR devicedevice

Mid-urethral mini-sling