Phase 3
N=263
Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00534365 ↗Enrolled (actual)
263
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Subjective Cure of Urinary Incontinence at 12 Months After Surgery — 77; 72 Participants — p=0.43
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tension-free vaginal tape (Device); TVT-SECUR device (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Cure of Urinary Incontinence at 12 Months After Surgery |
77; 72 | 0.43 |
| SECONDARY Post Operative Complications at 6 Week or Less |
5; 6; 9; 9; 0; 0 | — |
| SECONDARY Long Term Complications > 6 Weeks |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Patient Global Impression Improvement |
63; 67; 24; 24; 11; 9 | 0.64 |
| SECONDARY Incontinence Severity Index Score |
2.2; 1.5 | 0.015 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00534365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.