TOMUS-Trial Of Mid-Urethral Slings (TOMUS)

December 12, 2013 updated by: HealthCore-NERI
The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

597

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • California
      • San Diego, California, United States, 92110
        • Kaiser Permanente
      • San Diego, California, United States, 92103
        • University of California
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Michigan
      • Dearborn, Michigan, United States, 48123
        • Oakwood Hospital/Cancer Center
      • Royal Oak, Michigan, United States, 48123
        • William Beaumont Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Sciences Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Stress urinary incontinence (SUI) as evidenced by all of the following:
  • Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months
  • Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
  • Observation of leakage by provocative stress test at a bladder volume ≤ 300ml
  • Bladder capacity ≥ 200ml by stress test
  • Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower. If POP is Stage II-IV, PVR >100cc but ≤ 500cc is allowed
  • Eligible for both retropubic and transobturator procedures
  • No medical contraindications, e.g., current urinary tract infection (UTI), history of pelvic irradiation, history of lower urinary tract cancer
  • American Society of Anesthesiologists (ASA) class I, II, or III
  • No current intermittent catheterization
  • Available for 24-months of follow-up and able to complete study assessments, per clinician judgment
  • Signed consent form

Exclusion Criteria:

  • Age <21 years
  • Non-ambulatory (ambulatory with assistive devices does not exclude the patient)
  • Pregnancy by self-report or positive pregnancy test, or self-reported intention to ever become pregnant
  • Current chemotherapy or current or history of pelvic radiation therapy
  • Systemic disease known to affect bladder function (i.e., Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma)
  • Urethral diverticulum, current or previous (i.e. repaired)
  • Prior augmentation cystoplasty or artificial sphincter
  • Implanted nerve stimulators for urinary symptoms
  • History of synthetic sling for stress urinary incontinence
  • <12 months post-partum
  • Laparoscopic or open pelvic surgery <3 months*
  • Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome)
  • Participation in another treatment intervention trial that might influence the results of this trial
  • Need for concomitant surgery requiring an abdominal incision, use of graft material in the anterior compartment, or any use of synthetic graft material
  • Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or BE-DRI/E-BE-DRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)
Procedure: retropubic mid-urethral sling (TVT)
This trial is a comparison of two types of mid-urethral slings. The retropubic mid-urethral mesh sling is used for treatment of stress incontinence; this procedure was less invasive than the fascial sling procedures that were reference standards at the start of the study. Specifically, a synthetic tape is passed transvaginally at the midurethral level through the retropubic space.
Active Comparator: 2
transobturator mid-urethral sling (TVT-O and the Monarc) Two transobturator slings were used: the Tension-free Vaginal Tape Obturator (Gynecare), which is placed starting inside the vagina and coming out through the obturator foramen ("in-to-out") or the Monarc (American Medical System), which is placed starting in the groin area, passing through the obturator foramen, and then into the vagina ("out-to-in").
Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)
This trial is a comparison of two types of mid-urethral slings. The transobturator mid-urethral sling is used for treatment of stress incontinence; this procedure was developed to minimize the potential for bladder and bowel injuries associated with the retropubic sling, since the sling is passed through the obturator canal, avoiding the pelvic organs in the retropubic space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Treatment Success at 12 Months
Time Frame: 12 months

Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures

A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is <15g/24 hrs.
12 months
Subjective Treatment Success at 12 Months
Time Frame: 12 months
Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction at 12 Months
Time Frame: Follow-Up
Patient satisfaction was assessed at the 12 month visit with the questions, "how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage?" Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as "satisfied" and neutral, most dissatisfied and completely dissatisfied as "not satisfied".
Follow-Up
Change in Quality of Life From Baseline to 12 Months
Time Frame: Baseline - 12 months
Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).
Baseline - 12 months
Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months
Time Frame: 12 months
Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthCore-NERI

Investigators

  • Study Chair: Ann Gormley, M.D., Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 10, 2006

First Submitted That Met QC Criteria

May 10, 2006

First Posted (Estimate)

May 11, 2006

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK58229

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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