Status:
UNKNOWN
Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence
Lead Sponsor:
University of Helsinki
Conditions:
Urinary Stress Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- history of stress incontinence
- indications for surgical treatment
- positive cough stress test
- urgency score \< 7
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2010
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00379314
Start Date
April 1 2004
End Date
December 1 2010
Last Update
November 1 2006
Active Locations (1)
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1
Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital
Helsinki, Finland, 00029 HUS