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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00475839
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : January 10, 2013
Good Samaritan Hospital, Ohio
Greater Baltimore Medical Center
American Medical Systems
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
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 : December 2004
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Complications
  2. Postoperative pain [ Time Frame: 2 weeks, 6 weeks ]
  3. HRQOL [ Time Frame: 6 months, 12 months, 18 months, 24 months ]
  4. Sexual function [ Time Frame: 12 months, 24 months ]
  5. Global improvement in bladder function [ Time Frame: 6 months, 12 months, 18 months, 24 months ]
  6. Development of anterior vaginal prolapse [ Time Frame: 12 months, 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00475839

United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45520
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Good Samaritan Hospital, Ohio
Greater Baltimore Medical Center
American Medical Systems
Principal Investigator: Matthew D Barber, MD, MHS The Cleveland Clinic

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00475839     History of Changes
Other Study ID Numbers: CCF 7616
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by The Cleveland Clinic:
stress urinary incontinence
sling procedures
tension-free vaginal tape

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders