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

This study has been completed.
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00308009
First received: March 27, 2006
Last updated: January 4, 2008
Last verified: November 2007
  Purpose

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


Condition Intervention
Pelvic Organ Prolapse
Urinary Stress Incontinence
Procedure: Vaginal Repair for prolapse, TVT procedure
Procedure: TVT and Prolapse surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Any or no leakage of urine when coughing [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The cure of urinary stress incontinence (USI) by only prolapse surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 194
Study Start Date: February 2002
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Group I
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
Active Comparator: 2
Group II
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria: Not agreed to participate in randomization

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308009

Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Ellen Borstad, MD Michael Abdelnoor Phd, Department of epidemiology (same hospital)
  More Information

No publications provided

Responsible Party: Ellen Borstad, MD, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00308009     History of Changes
Other Study ID Numbers: TVT Prolapse study
Study First Received: March 27, 2006
Last Updated: January 4, 2008
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ullevaal University Hospital:
Pelvic Organ Prolapse
Urinary stress incontinence
Surgery

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence, Stress
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014