Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: A randomized controlled trial

Holly E. Richter, Kathryn L. Burgio, Linda Brubaker, Ingrid E. Nygaard, Wen Ye, Alison Weidner, Catherine S. Bradley, Victoria L. Handa, Diane Borello-France, Patricia S. Goode, Halina Zyczynski, Emily S. Lukacz, Joseph Schaffer, Matthew Barber, Susan Meikle, Cathie Spino

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)609-617
Number of pages9
JournalObstetrics and gynecology
Volume115
Issue number3
DOIs
StatePublished - Mar 2010
Externally publishedYes

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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