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Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence
This study is currenly Active, not recruiting patients.
Sponsored by:
The Cleveland Clinic
Purpose
The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal
tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary
incontinence.
Study Type: Intervention
| Condition | Intervention | Phase |
|
Stress Urinary Incontinence |
Array: Array Array: Array | Phase 3 |
Study Design:Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence
Further Study Details:
Expected Total Enrollment:
Study Dates:August 2007 -
Eligibility
Ages Eligible for Study- Min: 21 Years Max: N/A
Gender: Female
Criteria
Inclusion Criteria:
Urinary incontinence symptoms
Urodynamic stress incontinence confirmed with multichannel urodynamic testing
Age of at least 21 years
Desires surgical correction of stress urinary incontinence
Exclusion Criteria:
Post-void residual volume >100cc
Detrusor overactivity on preoperative multichannel urodynamic testing
History of previous synthetic, biologic or fascial sub-urethral sling
Desires future childbearing
History of bleeding diathesis or current anti-coagulation therapy
Current genitourinary fistula or urethral diverticulum
Reversible cause of incontinence (i.e. drug effect)
Contraindication to surgery
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier: NCT00534365
More Information
Record Last Reviewed:April 2010
Last Updated:June 16, 2010
Record First Recieved:September 20, 2007
ClinicalTrials.gov Identifier:NCT00534365
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 08, 2010
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