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ATLAS: Ambulatory Treatments for Leakage Associated With Stress

Study:

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

Rationale:

n/a

Purpose:

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 Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Stress Urinary Incontinence
Mixed Stress and Urge Urinary Incontinence
Behavioral: Pelvic muscle training and exercises
Device: Intravaginal incontinence pessary
Device: Both pessary and pelvic muscle exercises
Phase 3

Verified by NICHD Pelvic Floor Disorders Network September, 2013

Sponsored by: NICHD Pelvic Floor Disorders Network
Information provided by: NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov identifier: NCT00270998

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Holly E Richter, PhD, MD., Study Chair

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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