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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00379314
Other study ID # 42/E8/04
Secondary ID
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
Est. primary completion date
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


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
See also
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Completed NCT01784172 - Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial Phase 2
Not yet recruiting NCT06469320 - Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners
Recruiting NCT02935803 - A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients N/A
Active, not recruiting NCT02039830 - Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women N/A
Recruiting NCT04817839 - Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures N/A