A Phase 3 interventional study of Tension-free Vaginal Tape and Monarc sub-fascial hammock in Stress Urinary Incontinence, sponsored by The Cleveland Clinic. Completed at 3 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.
Sponsored by The Cleveland Clinic · Phase 3, Interventional, and Treatment
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 180 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Tension-free Vaginal Tape
Device: Monarc sub-fascial hammock
The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention
Time frame: 12 months
Complications
Postoperative pain
Time frame: 2 weeks, 6 weeks
HRQOL
Time frame: 6 months, 12 months, 18 months, 24 months
Sexual function
Time frame: 12 months, 24 months
Global improvement in bladder function
Time frame: 6 months, 12 months, 18 months, 24 months
Development of anterior vaginal prolapse
Time frame: 12 months, 24 months
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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