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

This study has been completed.
Sponsor:
Collaborators:
Good Samaritan Hospital, Ohio
Greater Baltimore Medical Center
American Medical Systems
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00475839
First received: May 17, 2007
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Stress Urinary Incontinence
Device: Tension-free Vaginal Tape
Device: Monarc sub-fascial hammock
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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:
  • Complications
  • Postoperative pain [ Time Frame: 2 weeks, 6 weeks ]
  • HRQOL [ Time Frame: 6 months, 12 months, 18 months, 24 months ]
  • Sexual function [ Time Frame: 12 months, 24 months ]
  • Global improvement in bladder function [ Time Frame: 6 months, 12 months, 18 months, 24 months ]
  • Development of anterior vaginal prolapse [ Time Frame: 12 months, 24 months ]

Enrollment: 180
Study Start Date: December 2004
Study Completion Date: July 2007
Arms Assigned Interventions
Active Comparator: Tension-free Vaginal Tape Device: Tension-free Vaginal Tape
Active Comparator: Monarc Sub-fascial hammock Device: Monarc sub-fascial hammock

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475839

Locations
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
Investigators
Principal Investigator: Matthew D Barber, MD, MHS The Cleveland Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00475839     History of Changes
Other Study ID Numbers: CCF 7616
Study First Received: May 17, 2007
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 01, 2014