NCT00270998
ATLAS: Ambulatory Treatments for Leakage Associated With Stress
PHASE3
COMPLETED
NCT00270998
INTERVENTIONAL
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
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.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Stress Urinary Incontinence
Urinary Incontinence
- TREATMENT
-
- Type: BEHAVIORAL
- Name: Behavioral Therapy
- Description: Pelvic muscle training and exercises
- Arm Group Labels: Behavioral Therapy
-
- Type: DEVICE
- Name: Intravaginal Pessary
- Description: Intravaginal pessary
- Arm Group Labels: Intravaginal Pessary
-
- Type: DEVICE
- Name: Pessary combined with behavioral therapy
- Description: Intravaginal pessary and behavioral therapy
- Arm Group Labels: Pessary combined with behavioral therapy
- NICHD Pelvic Floor Disorders Network