NCT00534365CompletedPhase 3
A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 281
- Locations
- 14
- Primary Endpoint
- Subjective Cure of Urinary Incontinence at 12 Months After Surgery
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Subjective Cure of Urinary Incontinence at 12 Months After Surgery
Time Frame: 12 months
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
Secondary Outcomes
- Long Term Complications > 6 Weeks(6 weeks-12 months)
- Patient Global Impression Improvement(12 months)
- Post Operative Complications at 6 Week or Less(6 week)
- Incontinence Severity Index Score(12 months)
Investigators
Study Sites (14)
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