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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475839
• Other study ID #: CCF 7616
• Status: Completed
• Phase: Phase 3
• First received: May 17, 2007
• Last updated: January 9, 2013
• Start date: December 2004
• Est. completion date: July 2007

Study information

• Verified date: January 2013
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Tension-free Vaginal Tape

• Monarc sub-fascial hammock

Locations

Country	Name	City	State
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
The Cleveland Clinic	American Medical Systems, Good Samaritan Hospital, Ohio, Greater Baltimore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention		12 months
Secondary	Complications
Secondary	Postoperative pain		2 weeks, 6 weeks
Secondary	HRQOL		6 months, 12 months, 18 months, 24 months
Secondary	Sexual function		12 months, 24 months
Secondary	Global improvement in bladder function		6 months, 12 months, 18 months, 24 months
Secondary	Development of anterior vaginal prolapse		12 months, 24 months