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Randomized Controlled Trial
. 2010 Mar;115(3):609-617.
doi: 10.1097/AOG.0b013e3181d055d4.

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

Holly E Richter  1 , 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; Pelvic Floor Disorders Network
Affiliations
Randomized Controlled Trial

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

Holly E Richter et al. Obstet Gynecol. 2010 Mar.

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.

Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00270998.

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Enrollment and Disposition.
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References

    1. Abrams P, Cardozo L, Fall M, et al. The Standardization of terminology of lower urinary tract function: Report from the Standardization Sub-committee of the International Continence Society. Neurourol Urodynam. 2002;21:167–78. - PubMed
    1. Milsom I, Altman D, Lapitan MC, Nelson R, Sillen U, Thom D. Epidemiology of urinary (UI) and Faecal (FI) Incontinence and Pelvic Organ Prolapse. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence; 4th International Consultation on Incontinence; Paris: Health Publication Ltd; 2009. pp. 35–111.
    1. Hay-Smith J, Berghmans B, Burgio K, et al. Adult Conservative Management. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence; 4th International Consultation on Incontinence; Paris: Health Publication Ltd; 2009. pp. 1025–1120.
    1. Hay-Smith EJC, Bo K, Berghmans LCM, et al. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst. 2002:CD001407. Rev 1. - PubMed
    1. Shamliyan TA, Kane RL, Wyman J, Wilt TJ. Systematic review: Randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med. 2008;148:459–73. - PubMed

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