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

NCT00308009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2015-04-28

No results posted yet for this study

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

Conditions

  • Pelvic Organ Prolapse
  • Urinary Stress Incontinence

Interventions

PROCEDURE

Vaginal Repair for prolapse, TVT procedure

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

PROCEDURE

TVT and Prolapse surgery

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

Sponsors & Collaborators

  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • Ellen Borstad, MD · Michael Abdelnoor Phd, Department of epidemiology (same hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2007-09-30
Completion
2007-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00308009 on ClinicalTrials.gov