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
|
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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 |
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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Group I, Prolapse repair and TVT concomitantly
|
Procedure: Vaginal Repair for prolapse, TVT procedure
Other Names:
Procedure: TVT and Prolapse surgery
|
Active Comparator: 2
Group II, Prolapse repair and TVT 3 months afterwards if necessary
|
Procedure: Vaginal Repair for prolapse, TVT procedure
Other Names:
Procedure: TVT and Prolapse surgery
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- Any or no leakage of urine when coughing [ Time Frame: 1 year ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -
Exclusion Criteria: Not agreed to participate in randomization

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
Principal Investigator: | Ellen Borstad, MD | Michael Abdelnoor Phd, Department of epidemiology (same hospital) |
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 |