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TOMUS-Trial Of Mid-Urethral Slings

Phase 4
21 Years
Open (Enrolling)
Urinary Incontinence

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Trial Information

TOMUS-Trial Of Mid-Urethral Slings

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Treatment Success at 12 Months

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Ann Gormley, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Federal Government

Study ID:




Start Date:

April 2006

Completion Date:

June 2013

Related Keywords:

  • Urinary Incontinence
  • Urinary Incontinence, Stress
  • Surgery
  • Urinary Incontinence



University of Alabama Birmingham, Alabama  
Loyola University Medical Center Maywood, Illinois  60153
William Beaumont Hospital Royal Oak, Michigan  48073
University of Pittsburgh Pittsburgh, Pennsylvania  15261
University of Utah Salt Lake City, Utah  
University of Maryland Baltimore, Maryland  21201
Kaiser Permanente Sacramento, California  
University of California San Francisco, California  94108
University of Texas Health Sciences Center San Antonio, Texas  
Oakwood Hospital/Cancer Center Dearborn, Michigan  48123
University of Texas Southwestern Dallas, Texas  75390