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

University of Helsinki

Status and phase: Unknown; Phase 3

Conditions: Urinary Stress Incontinence

Treatments: Procedure: Surgery for female stress urinary incontinence; Procedure: TVT and TVT-O minimally invasive surgical procedures

Study type: Interventional

Funder types: Other

Identifiers

NCT00379314

42/E8/04

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)