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Clinical Trials/NCT00308009
NCT00308009CompletedNot Applicable

Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery

Ullevaal University Hospital0 sites194 target enrollmentStarted: February 1, 2002Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
194
Primary Endpoint
Any or no leakage of urine when coughing
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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(1 year)
  • Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI(1 year)

Investigators

Sponsor
Ullevaal University Hospital
Sponsor Class
Other

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