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Clinical Trials/NCT00379314
NCT00379314
Unknown
Phase 3

A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence

University of Helsinki1 site in 1 country260 target enrollmentApril 2004
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ConditionsUrinary Stress Incontinence

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Urinary Stress Incontinence
Sponsor
University of Helsinki
Enrollment
260
Locations
1
Primary Endpoint
Objective cure rate by stress test and pad weighing test
Last Updated
19 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2004
End Date
December 2010
Last Updated
19 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •history of stress incontinence
  • •indications for surgical treatment
  • •positive cough stress test
  • •urgency score \< 7

Exclusion Criteria

  • •prior incontinence surgery
  • •need of concomitant surgery
  • •post void residual urine volume \< 100 ml
  • •urinary tract anomalies
  • •urinary tract infection
  • •more than 3 urinary tract infection within last year
  • •more than grade 2 urogenital prolapse
  • •Body mass index \> 35
  • •Radiotherapy of the pelvic region
  • •active malignancy

Outcomes

Primary Outcomes

Objective cure rate by stress test and pad weighing test

Complications

Secondary Outcomes

  • Quality of life questionnaires

Study Sites (1)

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