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

Phase 3

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Tension-free Vaginal Tape; Device: Monarc sub-fascial hammock

• Registration Number: NCT00475839
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-17
• Study First Posted: 2007-05-21
• Study Completion: 2007-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-09
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tension-free Vaginal Tape	Tension-free Vaginal Tape	-
Monarc Sub-fascial hammock	Monarc sub-fascial hammock	-

Primary Outcome Measures

Name	Time	Method
The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention	12 months

Secondary Outcome Measures

Name	Time	Method
Complications
Postoperative pain	2 weeks, 6 weeks
HRQOL	6 months, 12 months, 18 months, 24 months
Sexual function	12 months, 24 months
Global improvement in bladder function	6 months, 12 months, 18 months, 24 months
Development of anterior vaginal prolapse	12 months, 24 months

Trial Locations

Locations (3)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Greater Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States