title: Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT00270998.
authors.affiliation: From 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.
authors.forename: Holly E
authors.initials: HE
authors.lastname: Richter
authors.forename: Kathryn L
authors.initials: KL
authors.lastname: Burgio
authors.forename: Linda
authors.initials: L
authors.lastname: Brubaker
authors.forename: Ingrid E
authors.initials: IE
authors.lastname: Nygaard
authors.forename: Wen
authors.initials: W
authors.lastname: Ye
authors.forename: Alison
authors.initials: A
authors.lastname: Weidner
authors.forename: Catherine S
authors.initials: CS
authors.lastname: Bradley
authors.forename: Victoria L
authors.initials: VL
authors.lastname: Handa
authors.forename: Diane
authors.initials: D
authors.lastname: Borello-France
authors.forename: Patricia S
authors.initials: PS
authors.lastname: Goode
authors.forename: Halina
authors.initials: H
authors.lastname: Zyczynski
authors.forename: Emily S
authors.initials: ES
authors.lastname: Lukacz
authors.forename: Joseph
authors.initials: J
authors.lastname: Schaffer
authors.forename: Matthew
authors.initials: M
authors.lastname: Barber
authors.forename: Susan
authors.initials: S
authors.lastname: Meikle
authors.forename: Cathie
authors.initials: C
authors.lastname: Spino
mesh_terms: D000328:Adult; D001521:Behavior Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D008875:Middle Aged; D017060:Patient Satisfaction; D010570:Pessaries; D014550:Urinary Incontinence, Stress / Q000628:therapy*