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Citation
Tennstedt, Sharon (2008). Behavior Enhances Drug Reduction of Incontinence (BE-DRI) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/sjgp-bq76
Data Availability Statement
Data from the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) [(Version 1) https://doi.org/10.58020/sjgp-bq76] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The BE-DRI study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the BE-DRI (https://doi.org/10.58020/sjgp-bq76) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the BE-DRI study and does not necessarily reflect the opinions or views of the BE-DRI study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: Aug 10, 2008)
Resource Availability
  • Data Available for Request
  • Specimens Not Available
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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.

Eligibility 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.

Research Area

Urologic Diseases

Study Type

Interventional

Study Sites

9

Study Start Date

2004-08

Study End Date

2006-08

Condition

Urinary Incontinence

Keywords

Urinary Incontinence, Antimuscarinic Drug Therapy, Urogenital Disease, Urge Incontinence, Behavioral Training

NIDDK Division

Division of Kidney, Urologic, and Hematologic Diseases

307
Participants

Target Population
Adults

Public Documents Table
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Datasets (28)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Form F211 Dataset
Contains data from Form F211 - Intervention Visit305sas7bdat (49 KB); csv (14.56 KB)
Form F288 Dataset
Contains data from Form F288 - 10 Week Expectation Survey174sas7bdat (13 KB); csv (2.92 KB)
Form F244 Dataset
Contains data from Form F244 - End of Stage 1283sas7bdat (65 KB); csv (17.92 KB)
Form F208 QxQ Dataset
Contains data from Form F208 - OABq Patient Survey QxQ1194sas7bdat (369 KB); csv (99.91 KB)
Form F216 Dataset
Contains data from Form F216 - Visit 05 Bladder Diary Summary274sas7bdat (305 KB); csv (102.93 KB)
Form F201 Dataset
Contains data from Form F201 Preliminary Screening Part 1307sas7bdat (177 KB); csv (49.25 KB)
Form F218 Dataset
Contains data from Form F218 - Baseline Expectation Survey173sas7bdat (81 KB); csv (18.05 KB)
Form F202 Dataset
Contains data from Form F202 - Preliminary Screening Part 2307sas7bdat (81 KB); csv (20.87 KB)
Form F205 QxQ Dataset
Contains data from Form F205 - Symptoms Checklist Self-Administered QxQ2375sas7bdat (513 KB); csv (146.29 KB)
Form F233 Dataset
Contains data from Form F233 - Intervention Visit 3-4573sas7bdat (177 KB); csv (59.1 KB)
Form F265 Dataset
Contains data from Form F265 - Follow-Up Physical Systems Audit747sas7bdat (49 KB); csv (21.04 KB)
Form F204 Dataset
Contains data from Form F204 - Baseline History Physical Exam307sas7bdat (177 KB); csv (56.8 KB)
Form F264 Dataset
Contains data from Form F264 - Follow-Up PC POPQ Assessment520sas7bdat (85 KB); csv (29.54 KB)
Form F203 Dataset
Contains data from Form F203 - Baseline Medication Audit307sas7bdat (37 KB); csv (9.79 KB)
Form F263 Dataset
Contains data from Form F263 - Follow-Up Medication Audit Data Entry1576sas7bdat (145 KB); csv (60.34 KB)
Form F280 Dataset
Contains data from Form F280 - Final Status307sas7bdat (33 KB); csv (12.29 KB)
Form F266 Dataset
Contains data from Form F266 - Follow-Up Bladder Diary Summary895sas7bdat (641 KB); csv (202.64 KB)
Form F262 Dataset
Contains data from Form F262 - SUI Treatment Status465sas7bdat (25 KB); csv (9.45 KB)
Form F267 Dataset
Contains data from Form F267 - Follow-Up Patient Survey1192sas7bdat (1.27 MB); csv (352.05 KB)
Form F261 Dataset
Contains data from Form F261 - UI Treatment Status990sas7bdat (45 KB); csv (20.11 KB)
Form F206 Dataset
Contains data from Form F206 - Baseline Bladder Diary Summary307sas7bdat (353 KB); csv (121.48 KB)
Form F205 Dataset
Contains data from Form F205 - Symptoms Checklist Self-Administered307sas7bdat (81 KB); csv (18.11 KB)
Form F222 Dataset
Contains data from Form F222 - Intervention Visit 2293sas7bdat (65 KB); csv (19.35 KB)
Form F209 Dataset
Contains data from Form F209 - Eligibility Confirmation Randomization307sas7bdat (81 KB); csv (21.77 KB)
Form F207 Dataset
Contains data from Form F207 - Baseline Patient Survey307sas7bdat (353 KB); csv (86.16 KB)
Form F255 Dataset
Contains data from Form F255 - Exercise Questionnaire865sas7bdat (177 KB); csv (57.96 KB)
Form F256 Dataset
Contains data from Form F256 - Exercise Questionnaire Visit 5 and Beyond1272sas7bdat (241 KB); csv (80.77 KB)
Form F208 Dataset
Contains data from Form F208 - OABq Patient Survey307sas7bdat (113 KB); csv (26.59 KB)
Specimens (0)
There are currently no specimens available