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TOMUS-Trial Of Mid-Urethral Slings


Phase 4
21 Years
N/A
Open (Enrolling)
Female
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
BE-DRI/E-BE-DRI

Type of Study:

Interventional

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:

No

Principal Investigator

Ann Gormley, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Federal Government

Study ID:

DK58229

NCT ID:

NCT00325039

Start Date:

April 2006

Completion Date:

June 2013

Related Keywords:

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

Name

Location

University of AlabamaBirmingham, Alabama  
Loyola University Medical CenterMaywood, Illinois  60153
William Beaumont HospitalRoyal Oak, Michigan  48073
University of PittsburghPittsburgh, Pennsylvania  15261
University of UtahSalt Lake City, Utah  
University of MarylandBaltimore, Maryland  21201
Kaiser PermanenteSacramento, California  
University of CaliforniaSan Francisco, California  94108
University of Texas Health Sciences CenterSan Antonio, Texas  
Oakwood Hospital/Cancer CenterDearborn, Michigan  48123
University of Texas SouthwesternDallas, Texas  75390