At a glance
ClinicalIndex Comparison Record- ✓Stress urinary incontinence or stress-predominant mixed urinary incontinence with ≥2 stress incontinence episodes on 7-day bladder diary, where stress episodes exceed urge episodes
- ✓Urinary incontinence present for ≥3 months
- ✓Ambulatory adult women
- ✓Stage 0-I-II pelvic organ prolapse
- ✕Continual/continuous urine leakage
- ✕Pregnant or planning pregnancy within 1 year
- ✕Active urinary tract infection
- ✕Urinary retention
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ATLAS: Ambulatory Treatments for Leakage Associated With Stress, A Randomized Trial of Pelvic Muscle Exercise Versus Incontinence Pessary Versus Both for Women With Stress or Mixed Urinary Incontinence
In Brief
A Phase 3 clinical trial evaluating Behavioral Therapy, Intravaginal Pessary, and 1 other intervention for Stress Urinary Incontinence and Urinary Incontinence. Completed, enrolled 445 participants across 8 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Pelvic muscle training and exercises
Intravaginal pessary
Intravaginal pessary and behavioral therapy