Status:
COMPLETED
TOMUS-Trial Of Mid-Urethral Slings
Lead Sponsor:
Carelon Research
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
21+ years
Phase:
PHASE4
Brief Summary
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-ure...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
597 Patients enrolled
Trial Details
Trial ID
NCT00325039
Start Date
April 1 2006
End Date
June 1 2013
Last Update
January 14 2014
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California
San Diego, California, United States, 92103
3
Kaiser Permanente
San Diego, California, United States, 92110
4
Loyola University Medical Center
Maywood, Illinois, United States, 60153