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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00475839

Collaborator

Good Samaritan Hospital, Ohio (Other), Greater Baltimore Medical Center (Other), American Medical Systems (Industry)

180

Enrollment

Locations

Arms

30.9

Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: Tension-free Vaginal Tape Device: Monarc sub-fascial hammock	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

A Randomized Trial Comparing the Monarc Subfascial Hammock Procedure With Tension-free Vaginal Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence

Study Start Date :

Dec 1, 2004

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tension-free Vaginal Tape	Device: Tension-free Vaginal Tape
Active Comparator: Monarc Sub-fascial hammock	Device: Monarc sub-fascial hammock

Arm

Intervention/Treatment

Active Comparator: Tension-free Vaginal Tape

Device: Tension-free Vaginal Tape

Active Comparator: Monarc Sub-fascial hammock

Device: Monarc sub-fascial hammock

Outcome Measures

Primary Outcome Measures

The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention [12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Greater Baltimore Medical Center	Baltimore	Maryland	United States	21204
2	Good Samaritan Hospital	Cincinnati	Ohio	United States	45520
3	Cleveland Clinic	Cleveland	Ohio	United States	44195