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TOMUS-Trial Of Mid-Urethral Slings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00325039
First received: May 10, 2006
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence
Procedure: retropubic mid-urethral sling (TVT)
Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TOMUS-Trial Of Mid-Urethral Slings

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • Objective Treatment Success at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.


  • Subjective Treatment Success at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient Satisfaction at 12 Months [ Time Frame: Follow-Up ] [ Designated as safety issue: No ]
    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".

  • Change in Quality of Life From Baseline to 12 Months [ Time Frame: Baseline - 12 months ] [ Designated as safety issue: No ]
    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).

  • Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 597
Study Start Date: April 2006
Study Completion Date: June 2013
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325039

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
Kaiser Permanente
San Diego, California, United States, 92110
University of California
San Diego, California, United States, 92103
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Oakwood Hospital/Cancer Center
Dearborn, Michigan, United States, 48123
William Beaumont Hospital
Royal Oak, Michigan, United States, 48123
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229-3900
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
New England Research Institutes
Investigators
Study Chair: Ann Gormley, M.D. Dartmouth-Hitchcock Medical Center
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00325039     History of Changes
Other Study ID Numbers: DK58229
Study First Received: May 10, 2006
Results First Received: March 26, 2012
Last Updated: December 12, 2013
Health Authority: United States: Federal Government

Keywords provided by New England Research Institutes:
Urinary Incontinence, Stress
Surgery

Additional relevant MeSH terms:
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 19, 2014