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Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized
Holly E Richter1, Kathryn L Burgio, Linda Brubaker
1From the University of Alabama at Birmingham, Birmingham, Alabama; Birmingham VA Medical Center, Birmingham, Alabama; Loyola University, Maywood, Illinois; University of Utah, Salt Lake City, Utah; University of Michigan, Ann Arbor, Michigan; Duke University, Durham, North Carolina; University of Iowa, Iowa City, Iowa; Johns Hopkins School of Medicine, Baltimore, Maryland; Duquesne University, Pittsburgh, Pennsylvania; Magee-Womens Hospital, Pittsburgh, Pennsylvania; University of California San Diego, San Diego, California; University of Texas Southwestern, Dallas, Texas; Cleveland Clinic, Cleveland, Ohio; and National Institutes of Health, Bethesda, Maryland.
Objective:
To compare the effectiveness of a continence pessary to evidence-based behavioral therapy for stress incontinence and to assess whether combined pessary and behavioral therapy is superior to single-modality therapy.
Methods:
This was a multisite, randomized clinical trial (Ambulatory Treatments for Leakage Associated with Stress Incontinence [ATLAS]) that randomly assigned 446 women with stress incontinence to pessary, behavioral therapy, or combined treatment. Primary outcome measures, at 3 months, were Patient Global Impression of Improvement and the stress incontinence subscale of the Pelvic Floor Distress Inventory. A priori, to be considered clinically superior, combination therapy had to be better than both single-modality therapies. Outcome measures were repeated at 6 and 12 months. Primary analyses used an intention-to-treat approach.
Results:
At 3 months, scores from 40% of the pessary group and 49% of the behavioral group were "much better" or "very much better" on the Patient Global Impression of Improvement (P=.10). Compared with the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% compared with 33%, P=.006) and treatment satisfaction (75% compared with 63%, P=.02). Combination therapy was significantly better than pessary as shown on the Patient Global Impression of Improvement (53%, P=.02) and Pelvic Floor Distress Inventory (44%, P=.05) but not better than behavioral therapy; it was therefore not superior to single-modality therapy. Group differences were not sustained to 12 months on any measure, and patient satisfaction remained above 50% for all treatment groups.
Conclusion:
Behavioral therapy resulted in greater patient satisfaction and fewer bothersome incontinence symptoms than pessary at 3 months, but differences did not persist to 12 months. Combination therapy was not superior to single-modality therapy.
Clinical Trial Registration:
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00270998.
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