Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

General Description

Urge incontinence, the involuntary urine loss associated with a strong desire to void, is one of several types of urinary incontinence (UI) and has one of the greatest impacts on quality of life. Common treatments for urge incontinence include behavioral training and antimuscarinic medications, but long-term adherence with medication therapy can be difficult to achieve. The Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study was a multicenter, randomized clinical trial that combined behavioral training and pharmacological treatment with the goal of improving patient outcomes. The primary aim of this randomized clinical trial was to determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared to drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing medication.

Participants with urge incontinence (defined as urge symptom index > stress symptom index on the Medical, Epidemiological, and Social Aspects of Aging Questionnaire) were enrolled in the study and randomly assigned either to drug therapy alone or combined behavioral and drug therapy. Drug therapy was tolterodine tartrate at a dose of 4 mg per day. Combination therapy included drug and behavioral training, which consisted of teaching pelvic floor muscle control and exercises, delayed voiding to increase voiding interval, individualized fluid management, and strategies to diminish urgency, suppress bladder contractions, and prevent both stress and urge incontinence. Treatment was discontinued for both groups after 10 weeks. The primary outcome measure, assessed at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcome measures included reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and health-related quality of life.

Results showed that the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups, although a higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks. The study concluded that the addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence.

Objectives

The primary aim of the study was to determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy.

Outcome Measure

The primary outcome measure, which was assessed at 8 months, was a composite of two endpoints: (1) successful drug withdrawal (i.e. not requesting any other treatment for incontinence) and (2) achieving and maintaining ≥ 70% reduction from baseline in the frequency of incontinence episodes reported on a bladder diary.

Secondary outcome measures included reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and health-related quality of life.

Criteria

Women with urge incontinence only or predominant urge incontinence (defined as urge symptom index > stress symptom index on the Medical Epidemiological, and Social Aspects of Aging Questionnaire) who met the following criteria were eligible for the study:

• At least 7 episodes of incontinence reported in a 7-day bladder diary
• Persistent incontinence for at least 3 months
• No current use of antimuscarinics or other medications that could impact urinary incontinence
• No evidence that incontinence was secondary to neurologic or other systemic diseases.

Outcome

Results showed that the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups, although a higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks. Combination therapy yielded better outcomes over time for patient satisfaction and perceived improvement but not health-related quality of life.

The study concluded that the addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy was shown to have a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.