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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00308009

First Posted: March 28, 2006

Last Update Posted: April 28, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Oslo University Hospital

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 Intervention Model: Parallel Assignment Masking: None (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:

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:

Any or no leakage of urine when coughing [ Time Frame: 1 year ]

Secondary Outcome Measures:

The cure of urinary stress incontinence (USI) by only prolapse surgery [ Time Frame: 1 year ]
Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI [ Time Frame: 1 year ]


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, Prolapse repair and TVT concomitantly	Procedure: Vaginal Repair for prolapse, TVT procedure TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair Other Names: Incontinence surgery Mid-urethra sling Prolapse surgery. Prolapse repair Procedure: TVT and Prolapse surgery TVT at the time of Prolapse surgery TVT 3 months after Prolapse Surgery
Active Comparator: 2 Group II, Prolapse repair and TVT 3 months afterwards if necessary	Procedure: Vaginal Repair for prolapse, TVT procedure TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair Other Names: Incontinence surgery Mid-urethra sling Prolapse surgery. Prolapse 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

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:	Ellen Borstad, MD, Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00308009 History of Changes
Other Study ID Numbers:	TVT Prolapse study
First Submitted:	March 27, 2006
First Posted:	March 28, 2006
Last Update Posted:	April 28, 2015
Last Verified:	November 2007

Keywords provided by Oslo University Hospital:


Pelvic Organ Prolapse Urinary stress incontinence Surgery

Additional relevant MeSH terms:


Prolapse Pelvic Organ Prolapse Urinary Incontinence, Stress Pathological Conditions, Anatomical Urinary Incontinence	Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms

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