NCT00475839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2004

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

First QC Date

May 17, 2007

Last Update Submit

January 9, 2013

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinencesling procedurestension-free vaginal tapetransobturator

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (6)

  • Complications

  • Postoperative pain

    2 weeks, 6 weeks

  • HRQOL

    6 months, 12 months, 18 months, 24 months

  • Sexual function

    12 months, 24 months

  • Global improvement in bladder function

    6 months, 12 months, 18 months, 24 months

  • +1 more secondary outcomes

Study Arms (2)

Tension-free Vaginal Tape

ACTIVE COMPARATOR
Device: Tension-free Vaginal Tape

Monarc Sub-fascial hammock

ACTIVE COMPARATOR
Device: Monarc sub-fascial hammock

Interventions

Tension-free Vaginal TapeDEVICE
Tension-free Vaginal Tape
Monarc sub-fascial hammockDEVICE
Monarc Sub-fascial hammock

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Urinary incontinence symptoms
  • Urodynamic stress incontinence confirmed with multichannel urodynamic testing
  • Age of at least 21 years
  • Desires surgical correction of stress urinary incontinence

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45520, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • 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.

    PMID: 18310363DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Matthew D Barber, MD, MHS

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2007

First Posted

May 21, 2007

Study Start

December 1, 2004

Study Completion

July 1, 2007

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

US(3)