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

University of Helsinki260 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Urinary Stress Incontinence

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes