Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

Carelon Research

Status: Completed

Conditions: Urinary Incontinence (UI)

Treatments: Drug: Tolterodine; Behavioral: Behavioral training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00090584

BE-DRI (completed)

Details and patient eligibility

About

The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.

Enrollment: 307 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Female
• Urge predominant incontinence
• Incontinent > 3 mos
• Available for 8 mos of followup

Exclusion:

• Pregnancy or < 6 mos post-partum
• Hypersensitivity to drug (tolterodine)
• Systemic disease that affects bladder function (e.g., Parkinson's disease, Multiple Sclerosis, spinal cord injury)
• History of extensive behavior treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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307 participants in 2 patient groups

Combination therapy

Experimental group

Description:

Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.

Treatment:

Behavioral: Behavioral training

Drug: Tolterodine

Drug therapy alone

Active Comparator group

Description:

Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.

Treatment:

Drug: Tolterodine