NCT00090584

Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT00090584

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Behavior Enhances Drug Reduction of Incontinence

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Urinary Incontinence (UI)

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Tolterodine
- Description: 4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.
- Arm Group Labels: Combination therapy, Drug therapy alone
- Type: BEHAVIORAL
- Name: Behavioral training
- Description: Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.
- Arm Group Labels: Combination therapy

Sponsor

Carelon Research