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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00379314

Enrollment

260

Registered

2006-09-21

Start date

2004-04-30

Completion date

2010-12-31

Last updated

2006-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Stress Incontinence

Keywords

Incontinence, Urinary, Female, Surgery, Complications

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.

Interventions

PROCEDURETVT and TVT-O minimally invasive surgical procedures

PROCEDURESurgery for female stress urinary incontinence

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Complications	—
Objective cure rate by stress test and pad weighing test	—

Secondary

Measure	Time frame
Quality of life questionnaires	—

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026