Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse; Urinary Stress Incontinence
• Interventions: Procedure: Vaginal Repair for prolapse, TVT procedure; Procedure: TVT and Prolapse surgery

• Registration Number: NCT00308009
• Lead Sponsor: Ullevaal University Hospital

Brief Summary

It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

Detailed Description

All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.

Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-28
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2007-11
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

Inclusion Criteria

Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -

Exclusion Criteria

Not agreed to participate in randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TVT and Prolapse surgery	Group I, Prolapse repair and TVT concomitantly
2	TVT and Prolapse surgery	Group II, Prolapse repair and TVT 3 months afterwards if necessary
2	Vaginal Repair for prolapse, TVT procedure	Group II, Prolapse repair and TVT 3 months afterwards if necessary
1	Vaginal Repair for prolapse, TVT procedure	Group I, Prolapse repair and TVT concomitantly

Primary Outcome Measures

Name	Time	Method
Any or no leakage of urine when coughing	1 year

Secondary Outcome Measures

Name	Time	Method
The cure of urinary stress incontinence (USI) by only prolapse surgery	1 year
Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI	1 year