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

Ullevaal University Hospital194 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

194

Conditions

Pelvic Organ Prolapse Urinary Stress Incontinence

Interventions

Vaginal Repair for prolapse, TVT procedurePROCEDURE

1. TVT at the time of Vaginal Repair 2. TVT 3 months after Vaginal Repair

TVT and Prolapse surgeryPROCEDURE

1. TVT at the time of Prolapse surgery 2. TVT 3 months after Prolapse Surgery

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence - Exclusion Criteria: Not agreed to participate in randomization \-

Outcomes

Primary Outcomes

Any or no leakage of urine when coughing

Time frame: 1 year

Secondary Outcomes

The cure of urinary stress incontinence (USI) by only prolapse surgery

Time frame: 1 year

Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI

Time frame: 1 year

Data from ClinicalTrials.gov

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