Study Comparing Tension-free Vaginal Tape With the Monarc Procedure for Stress Urinary Incontinence
Completed · Phase 3
Conditions studied: Stress Urinary Incontinence
In brief
Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Many different surgical procedures have been described for the treatment of SUI and there is no general agreement as to the most effective. This study compares the safety and efficacy of the tension-free vaginal tape procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary incontinence.
Key facts
- Study ID
- NCT00475839
- Run by
- The Cleveland Clinic
- People needed
- 180
- Starts
- 2004-12-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2013-01-10
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
- Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurativa
- History of bleeding diathesis or current anti-coagulation therapy
- Inguinal lymphadenopathy or inguinal/vulvar mass
- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence (i.e. drug effect)
- Contraindication to surgery
Where it is running
- Greater Baltimore Medical Center — Baltimore, Maryland, United States
- Good Samaritan Hospital — Cincinnati, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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