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

Primary Purpose

Stress Urinary Incontinence

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Tension-free Vaginal Tape

Monarc sub-fascial hammock

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, sling procedures, tension-free vaginal tape, transobturator

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Greater Baltimore Medical Center
Good Samaritan Hospital
Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Tension-free Vaginal Tape

Monarc Sub-fascial hammock

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications

Postoperative pain

HRQOL

Sexual function

Global improvement in bladder function

Development of anterior vaginal prolapse

Full Information

NCT ID

NCT00475839

First Posted

May 17, 2007

Last Updated

January 9, 2013

Sponsor

The Cleveland Clinic

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00475839

Brief Title

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

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The Cleveland Clinic

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

Keywords

stress urinary incontinence, sling procedures, tension-free vaginal tape, transobturator

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tension-free Vaginal Tape

Arm Type

Active Comparator

Arm Title

Monarc Sub-fascial hammock

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Tension-free Vaginal Tape

Intervention Type

Device

Intervention Name(s)

Monarc sub-fascial hammock

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Complications

Title

Postoperative pain

Time Frame

2 weeks, 6 weeks

Title

HRQOL

Time Frame

6 months, 12 months, 18 months, 24 months

Title

Sexual function

Time Frame

12 months, 24 months

Title

Global improvement in bladder function

Time Frame

6 months, 12 months, 18 months, 24 months

Title

Development of anterior vaginal prolapse

Time Frame

12 months, 24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew D Barber, MD, MHS

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Greater Baltimore Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Good Samaritan Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45520

Country

United States

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18310363

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.

Results Reference

derived

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

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