Study Comparing Tension-free Vaginal Tape With the Monarc Procedure for Stress Urinary Incontinence

NeuroTherapia, Inc.

Status and phase: Completed; Phase 3

Conditions: Stress Urinary Incontinence

Treatments: Device: Monarc sub-fascial hammock; Device: Tension-free Vaginal Tape

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00475839

CCF 7616

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Tension-free Vaginal Tape

Active Comparator group

Treatment:

Device: Tension-free Vaginal Tape

Monarc Sub-fascial hammock

Active Comparator group

Treatment:

Device: Monarc sub-fascial hammock