Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence

Phase 3

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: tension-free vaginal tape; Device: TVT-SECUR device

• Registration Number: NCT00534365
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-24
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2017-01-09
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Results First Posted: 2017-06-09
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 281

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tension-free vaginal tape	Tension-free vaginal tape procedure (TVT)
2	TVT-SECUR device	TVT-SECUR device

Primary Outcome Measures

Name	Time	Method
Subjective Cure of Urinary Incontinence at 12 Months After Surgery	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 Outcome Measures

Name	Time	Method
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	The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).

Trial Locations

Locations (7)

Washington Hospital Center; 🇺🇸 Washington, D.C., District of Columbia, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Main Line Health; 🇺🇸 Paoli, Pennsylvania, United States

Greater Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States

Women & Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States