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A Randomized Controlled Trial

Kathryn L. Burgio, PhD; Julie L. Locher, MA; Patricia S. Goode, MD; J. Michael Hardin, PhD; B. Joan McDowell, PhD, CRNP; Marianne Dombrowski, DO; Dorothy Candib, MD

JAMA. 1998;280:1995-2000.

Context.— Urinary incontinence is a common condition caused by many factors with several treatment options.

Objective.— To compare the effectiveness of biofeedback-assisted behavioral treatment with drug treatment and a placebo control condition for the treatment of urge and mixed urinary incontinence in older community-dwelling women.

Design.— Randomized placebo-controlled trial conducted from 1989 to 1995.

Setting.— University-based outpatient geriatric medicine clinic.

Patients.— A volunteer sample of 197 women aged 55 to 92 years with urge urinary incontinence or mixed incontinence with urge as the predominant pattern. Subjects had to have urodynamic evidence of bladder dysfunction, be ambulatory, and not have dementia.

Intervention.— Subjects were randomized to 4 sessions (8 weeks) of biofeedback-assisted behavioral treatment, drug treatment (with oxybutynin chloride, possible range of doses, 2.5 mg daily to 5.0 mg 3 times daily), or a placebo control condition.

Main Outcome Measures.— Reduction in the frequency of incontinent episodes as determined by bladder diaries, and patients' perceptions of improvement and their comfort and satisfaction with treatment.

Results.— For all 3 treatment groups, reduction of incontinence was most pronounced early in treatment and progressed more gradually thereafter. Behavioral treatment, which yielded a mean 80.7% reduction of incontinence episodes, was significantly more effective than drug treatment (mean 68.5% reduction; P=.04) and both were more effective than the placebo control condition (mean 39.4% reduction; P<.001 and P=.009, respectively). Patient-perceived improvement was greatest for behavioral treatment (74.1% "much better" vs 50.9% and 26.9% for drug treatment and placebo, respectively). Only 14.0% of patients receiving behavioral treatment wanted to change to another treatment vs 75.5% in each of the other groups.

Conclusion.— Behavioral treatment is a safe and effective conservative intervention that should be made more readily available to patients as a first-line treatment for urge and mixed incontinence.

From the Departments of Medicine, School of Medicine (Drs Burgio, Goode, and Ms Locher), and Health Services Administration, School of Health Related Professions (Dr Hardin), University of Alabama at Birmingham; School of Nursing, Department of Health Promotion and Development, University of Pittsburgh (Dr McDowell) and Department of Medicine, Allegheny General Hospital (Dr Dombrowski), Pittsburgh, Pa; and Family Practice Residency Program, St Vincent Health Center, Erie, Pa (Dr Candib).

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