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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
History of Changes
  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:

U.S. FDA Resources

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 June 17, 2013