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Completed

NCT Number: NCT00475839

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

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Greater Baltimore Medical Center, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tension-free Vaginal Tape

Device

Monarc sub-fascial hammock

Device

Primary outcomes

  1. The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • American Medical Systems
  • Good Samaritan Hospital, Ohio
  • Greater Baltimore Medical Center

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
May 21, 2007
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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