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.
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.
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.
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:
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.
Urologic Diseases
Interventional
9
2004-08
2006-08
Urinary Incontinence
Urinary Incontinence, Antimuscarinic Drug Therapy, Urogenital Disease, Urge Incontinence, Behavioral Training
Division of Kidney, Urologic, and Hematologic Diseases
Document Name | Description | Document Type | File Format | Compliance | Download |
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Dataset Name | Description | # of Records | # of Variables | File Format(s) |
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Form F211 Dataset | Contains data from Form F211 - Intervention Visit | 305 | sas7bdat (49 KB); csv (14.56 KB) | |
Form F288 Dataset | Contains data from Form F288 - 10 Week Expectation Survey | 174 | sas7bdat (13 KB); csv (2.92 KB) | |
Form F244 Dataset | Contains data from Form F244 - End of Stage 1 | 283 | sas7bdat (65 KB); csv (17.92 KB) | |
Form F208 QxQ Dataset | Contains data from Form F208 - OABq Patient Survey QxQ | 1194 | sas7bdat (369 KB); csv (99.91 KB) | |
Form F216 Dataset | Contains data from Form F216 - Visit 05 Bladder Diary Summary | 274 | sas7bdat (305 KB); csv (102.93 KB) | |
Form F201 Dataset | Contains data from Form F201 Preliminary Screening Part 1 | 307 | sas7bdat (177 KB); csv (49.25 KB) | |
Form F218 Dataset | Contains data from Form F218 - Baseline Expectation Survey | 173 | sas7bdat (81 KB); csv (18.05 KB) | |
Form F202 Dataset | Contains data from Form F202 - Preliminary Screening Part 2 | 307 | sas7bdat (81 KB); csv (20.87 KB) | |
Form F205 QxQ Dataset | Contains data from Form F205 - Symptoms Checklist Self-Administered QxQ | 2375 | sas7bdat (513 KB); csv (146.29 KB) | |
Form F233 Dataset | Contains data from Form F233 - Intervention Visit 3-4 | 573 | sas7bdat (177 KB); csv (59.1 KB) | |
Form F265 Dataset | Contains data from Form F265 - Follow-Up Physical Systems Audit | 747 | sas7bdat (49 KB); csv (21.04 KB) | |
Form F204 Dataset | Contains data from Form F204 - Baseline History Physical Exam | 307 | sas7bdat (177 KB); csv (56.8 KB) | |
Form F264 Dataset | Contains data from Form F264 - Follow-Up PC POPQ Assessment | 520 | sas7bdat (85 KB); csv (29.54 KB) | |
Form F203 Dataset | Contains data from Form F203 - Baseline Medication Audit | 307 | sas7bdat (37 KB); csv (9.79 KB) | |
Form F263 Dataset | Contains data from Form F263 - Follow-Up Medication Audit Data Entry | 1576 | sas7bdat (145 KB); csv (60.34 KB) | |
Form F280 Dataset | Contains data from Form F280 - Final Status | 307 | sas7bdat (33 KB); csv (12.29 KB) | |
Form F266 Dataset | Contains data from Form F266 - Follow-Up Bladder Diary Summary | 895 | sas7bdat (641 KB); csv (202.64 KB) | |
Form F262 Dataset | Contains data from Form F262 - SUI Treatment Status | 465 | sas7bdat (25 KB); csv (9.45 KB) | |
Form F267 Dataset | Contains data from Form F267 - Follow-Up Patient Survey | 1192 | sas7bdat (1.27 MB); csv (352.05 KB) | |
Form F261 Dataset | Contains data from Form F261 - UI Treatment Status | 990 | sas7bdat (45 KB); csv (20.11 KB) | |
Form F206 Dataset | Contains data from Form F206 - Baseline Bladder Diary Summary | 307 | sas7bdat (353 KB); csv (121.48 KB) | |
Form F205 Dataset | Contains data from Form F205 - Symptoms Checklist Self-Administered | 307 | sas7bdat (81 KB); csv (18.11 KB) | |
Form F222 Dataset | Contains data from Form F222 - Intervention Visit 2 | 293 | sas7bdat (65 KB); csv (19.35 KB) | |
Form F209 Dataset | Contains data from Form F209 - Eligibility Confirmation Randomization | 307 | sas7bdat (81 KB); csv (21.77 KB) | |
Form F207 Dataset | Contains data from Form F207 - Baseline Patient Survey | 307 | sas7bdat (353 KB); csv (86.16 KB) | |
Form F255 Dataset | Contains data from Form F255 - Exercise Questionnaire | 865 | sas7bdat (177 KB); csv (57.96 KB) | |
Form F256 Dataset | Contains data from Form F256 - Exercise Questionnaire Visit 5 and Beyond | 1272 | sas7bdat (241 KB); csv (80.77 KB) | |
Form F208 Dataset | Contains data from Form F208 - OABq Patient Survey | 307 | sas7bdat (113 KB); csv (26.59 KB) |