Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial.
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.
Richter
Holly E
HE
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.
Burgio
Kathryn L
KL
Brubaker
Linda
L
Nygaard
Ingrid E
IE
Ye
Wen
W
Weidner
Alison
A
Bradley
Catherine S
CS
Handa
Victoria L
VL
Borello-France
Diane
D
Goode
Patricia S
PS
Zyczynski
Halina
H
Lukacz
Emily S
ES
Schaffer
Joseph
J
Barber
Matthew
M
Meikle
Susan
S
Spino
Cathie
C
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*