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

Ullevaal University Hospital

Status: Completed

Conditions: Pelvic Organ Prolapse; Urinary Stress Incontinence

Treatments: Procedure: Vaginal Repair for prolapse, TVT procedure; Procedure: TVT and Prolapse surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00308009

TVT Prolapse study

Details and patient eligibility

About

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

Full 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.

Enrollment: 194 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: Not agreed to participate in randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

1

Active Comparator group

Description:

Group I, Prolapse repair and TVT concomitantly

Treatment:

Procedure: TVT and Prolapse surgery

Procedure: Vaginal Repair for prolapse, TVT procedure

2

Active Comparator group

Description:

Group II, Prolapse repair and TVT 3 months afterwards if necessary

Treatment:

Procedure: TVT and Prolapse surgery

Procedure: Vaginal Repair for prolapse, TVT procedure