ATLAS: Ambulatory Treatments for Leakage Associated With Stress
Completed · Phase 3
Conditions studied: Stress Urinary Incontinence, Urinary Incontinence
In brief
Stress urinary incontinence is the uncontrollable leakage of urine with physical effort or stress, such as coughing, sneezing, or exercise. Treatment for stress incontinence can be surgical or non-surgical. Different non-surgical treatments include pelvic muscle exercises and pessary use. Pelvic muscle exercises (often known as "Kegel" exercises) train and strengthen the pelvic muscles and improve incontinence. A pessary is a medical device that fits inside the vagina to give the urethra and bladder extra support and prevent or reduce urinary incontinence. Exercises and pessary use can help women with stress incontinence but it is not known which treatment is better, or if a combination of the two treatments at the same time is best. This study will determine whether pelvic muscle training and exercises, pessary use, or a combination of both exercises and pessary is most effective at improving incontinence in women. The study's primary hypothesis is that pessary use is more effective than pelvic muscle exercises after 3 months of treatment.
Key facts
- Study ID
- NCT00270998
- Run by
- NICHD Pelvic Floor Disorders Network
- People needed
- 445
- Starts
- 2005-06-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2018-05-30
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Stress urinary incontinence or stress-predominant mixed urinary incontinence, with at least 2 episodes of stress incontinence on 7-day bladder diary and the number of stress incontinence episodes exceeding the number of urge incontinence episodes.
- Urinary incontinence for at least three months.
- Ambulatory adult women.
- Stage 0-I-II pelvic organ prolapse.
You may not qualify if…
- Continual urine leakage.
- Pregnancy or planning pregnancy within 1 year.
- Active urinary tract infection.
- Urinary retention.
- Currently on medication for incontinence.
- Currently using a pessary.
- Neurologic condition that affects bladder function.
Where it is running
- University of Alabama — Birmingham, Alabama, United States
- University of California, San Diego Medical Center — La Jolla, California, United States
- Loyola University — Maywood, Illinois, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- Duke University — Durham, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- University of Texas Southwestern — Dallas, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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