NCT00379314UnknownPhase 3
A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- University of Helsinki
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Objective cure rate by stress test and pad weighing test
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •hemophilia
- •anticoagulant treatment
- •neurological disorder or other disease which affects bladder function
- •anticholinergic treatment
- •use of duloxetine
- •do not understand the purpose of the trial
- •immobility
Outcomes
Primary Outcomes
Objective cure rate by stress test and pad weighing test
Complications
Secondary Outcomes
- Quality of life questionnaires
Investigators
Study Sites (1)
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