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Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence

NCT00379314 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2006-11-01

No results posted yet for this study

Summary

The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.

Conditions

  • Urinary Stress Incontinence

Interventions

PROCEDURE

TVT and TVT-O minimally invasive surgical procedures

PROCEDURE

Surgery for female stress urinary incontinence

Sponsors & Collaborators

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Carl G Nilsson, MD,PhD · Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital

  • Carl G Nilsson, MD,PhD · University of Helsinki

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Completion
2010-12-31

Countries

  • Finland

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 NCT00379314 on ClinicalTrials.gov