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

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ClinicalTrials.gov Identifier: NCT00308009
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : April 28, 2015
Sponsor:
Information provided by:
Oslo University Hospital

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Urinary Stress Incontinence Procedure: Vaginal Repair for prolapse, TVT procedure Procedure: TVT and Prolapse surgery Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
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
Study Start Date : February 2002
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Group I, Prolapse repair and TVT concomitantly
 Procedure: Vaginal Repair for prolapse, TVT procedure
  1. TVT at the time of Vaginal Repair
  2. TVT 3 months after Vaginal Repair
Other Names:
  • Incontinence surgery
  • Mid-urethra sling
  • Prolapse surgery.
  • Prolapse 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, Prolapse repair and TVT 3 months afterwards if necessary
 Procedure: Vaginal Repair for prolapse, TVT procedure
  1. TVT at the time of Vaginal Repair
  2. TVT 3 months after Vaginal Repair
Other Names:
  • Incontinence surgery
  • Mid-urethra sling
  • Prolapse surgery.
  • Prolapse repair
Procedure: TVT and Prolapse surgery
  1. TVT at the time of Prolapse surgery
  2. TVT 3 months after Prolapse Surgery


Outcome Measures
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Primary Outcome Measures :
  1. Any or no leakage of urine when coughing [ Time Frame: 1 year ]

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

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: March 28, 2006    Key Record Dates
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