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

Completed · Phase 3

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT00534365

Run by

The Cleveland Clinic

People needed

281

Starts

2007-08-01

Expected to finish

2011-04-01

Last updated by the study team

2017-06-09

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Urinary incontinence symptoms
• Urodynamic stress incontinence confirmed with multichannel urodynamic testing
• Age of at least 21 years
• Desires surgical correction of stress urinary incontinence

You may not qualify if…

• 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

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Main Line Health — Paoli, Pennsylvania, United States
• Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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