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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
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
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