Clinical trial NCT00475839: Study Comparing Tension-free Vaginal Tape With the Monarc Procedure for Stress Urinary Incontinence
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
sling procedures
tension-free vaginal tape
transobturator
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Good Samaritan Hospital, Ohio
name: Greater Baltimore Medical Center
name: American Medical Systems
First posted: 2007-05-21
Enrollment: 180
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention
timeFrame: 12 months
Secondary outcomes:
measure: Complications
measure: Postoperative pain
timeFrame: 2 weeks, 6 weeks
measure: HRQOL
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Sexual function
timeFrame: 12 months, 24 months
measure: Global improvement in bladder function
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Development of anterior vaginal prolapse
timeFrame: 12 months, 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Matthew D Barber, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e.