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

Urinary Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00379314
• Other study ID #: 42/E8/04
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 19, 2006
• Last updated: October 31, 2006
• Start date: April 2004
• Est. completion date: December 2010

Study information

• Verified date: September 2006
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Procedure:
• TVT and TVT-O minimally invasive surgical procedures

• Surgery for female stress urinary incontinence

Locations

Country	Name	City	State
Finland	Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications
Primary	Objective cure rate by stress test and pad weighing test
Secondary	Quality of life questionnaires

External Links

•   International urogynecological association