Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00090584
First received: August 27, 2004
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Urinary Incontinence (UI)
Drug: Tolterodine
Behavioral: Behavioral training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavior Enhances Drug Reduction of Incontinence

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • Proportion of Women Who Meet Definition of Success [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline.


Secondary Outcome Measures:
  • Change in Incontinence Episodes [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.

  • Change in Voids Per Day [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary

  • Symptom Distress [ Time Frame: baseline, 10 weeks and 8 months ] [ Designated as safety issue: No ]
    Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.

  • Symptom Bother [ Time Frame: baseline, 10 weeks and 8 months ] [ Designated as safety issue: No ]
    Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.

  • Satisfaction [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"

  • Satisfaction [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"

  • Symptom Improvement [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?"

  • Symptom Improvement [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?"


Enrollment: 307
Study Start Date: August 2004
Study Completion Date: August 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination therapy
Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
Drug: Tolterodine
4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.
Behavioral: Behavioral training
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.
Active Comparator: Drug therapy alone
Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.
Drug: Tolterodine
4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090584

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, California
University of California
San Diego, California, United States, 92103
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Oakwood Hospital and Medical Center
Royal Oak, Michigan, United States, 48123
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
New England Research Institutes
Investigators
Study Chair: William D Steers, M.D. University of Virginia
  More Information

Additional Information:
Publications:

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00090584     History of Changes
Other Study ID Numbers: BE-DRI (completed)
Study First Received: August 27, 2004
Results First Received: August 27, 2012
Last Updated: May 8, 2013
Health Authority: United States: Federal Government

Keywords provided by New England Research Institutes:
Urge urinary incontinence (UUI)
Drug/Behavior treatment

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014