Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After - Full Text View

Sponsored by:	Ullevaal University Hospital
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00308009

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

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery

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
1: Active Comparator Group I	Procedure: Vaginal Repair for prolapse, TVT procedure TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair Procedure: TVT and Prolapse surgery TVT at the time of Prolapse surgery TVT 3 months after Prolapse Surgery
2: Active Comparator Group II	Procedure: Vaginal Repair for prolapse, TVT procedure TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair Procedure: TVT and Prolapse surgery TVT at the time of Prolapse surgery 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

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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

Responsible Party:	Ullevaal University Hospital ( Ellen Borstad, MD )
Study ID Numbers:	TVT Prolapse study
Study First Received:	March 27, 2006
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00308009
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ullevaal University Hospital:

Pelvic Organ Prolapse
Urinary stress incontinence
Surgery

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urination Disorders
Gastrointestinal Diseases
Stress
Intestinal Diseases
Prolapse
Rectal Diseases

Signs and Symptoms
Urinary Incontinence, Stress
Digestive System Diseases
Urologic Diseases
Urinary Incontinence
Rectal Prolapse

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 14, 2009