Stress Urinary Incontinence
Conditions
Keywords
stress urinary incontinence, sling procedures, tension-free vaginal tape, transobturator
Brief summary
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.
Interventions
DEVICEMonarc sub-fascial hammock
Sponsors
Good Samaritan Hospital, Ohio
Greater Baltimore Medical Center
American Medical Systems
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pain | 2 weeks, 6 weeks |
| HRQOL | 6 months, 12 months, 18 months, 24 months |
| Complications | — |
| Global improvement in bladder function | 6 months, 12 months, 18 months, 24 months |
| Development of anterior vaginal prolapse | 12 months, 24 months |
| Sexual function | 12 months, 24 months |
Countries
United States
Outcome results
None listed