Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

This study has been completed.

First Received on August 27, 2004. Last Updated on April 25, 2011 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00090584

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	Phase
Urinary Incontinence	Drug: Tolterodine Behavioral: Combination Drug (tolterodine) and Behavior Treatment	Phase II Phase III

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:

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Primary Outcome: Composite [ Time Frame: 8 months ] [ Designated as safety issue: No ]
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 2. a >70% reduction in number of incontinent episodes as compared to baseline.

Secondary Outcome Measures:

Urinary symptoms [ Designated as safety issue: No ]
Frequency of urination and nocturia and urgency.

Estimated Enrollment:	300
Study Start Date:	August 2004
Study Completion Date:	August 2006
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

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, MS, spinal cord injury)
History of extensive behavior treatment

Contacts and Locations

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Study Chair:

William D Steers, M.D.

University of Virginia

More Information

Additional Information:

www.uitn.net This link exits the ClinicalTrials.gov site

Publications:

Urinary Incontinence Treatment Network (UITN). Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) study. Contemp Clin Trials. 2007 Jan;28(1):48-58. Epub 2006 Jun 18.

Borello-France D, Burgio KL, Goode PS, Markland AD, Kenton K, Balasubramanyam A, Stoddard AM; Urinary Incontinence Treatment Network. Adherence to behavioral interventions for urge incontinence when combined with drug therapy: adherence rates, barriers, and predictors. Phys Ther. 2010 Oct;90(10):1493-505. Epub 2010 Jul 29.

Brubaker L, Lukacz ES, Burgio K, Zimmern P, Norton P, Leng W, Johnson H, Kraus S, Stoddard A. Mixed incontinence: comparing definitions in non-surgical patients. Neurourol Urodyn. 2011 Jan;30(1):47-51.

Burgio KL, Kraus SR, Borello-France D, Chai TC, Kenton K, Goode PS, Xu Y, Kusek JW; Urinary Incontinence Treatment Network. The effects of drug and behavior therapy on urgency and voiding frequency. Int Urogynecol J Pelvic Floor Dysfunct. 2010 Jun;21(6):711-9. Epub 2010 Feb 9.

Burgio KL, Kraus SR, Menefee S, Borello-France D, Corton M, Johnson HW, Mallett V, Norton P, FitzGerald MP, Dandreo KJ, Richter HE, Rozanski T, Albo M, Zyczynski HM, Lemack GE, Chai TC, Khandwala S, Baker J, Brubaker L, Stoddard AM, Goode PS, Nielsen-Omeis B, Nager CW, Kenton K, Tennstedt SL, Kusek JW, Chang TD, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008 Aug 5;149(3):161-9.

Fitzgerald MP, Lemack G, Wheeler T, Litman HJ; Urinary Incontinence Treatment Network. Nocturia, nocturnal incontinence prevalence, and response to anticholinergic and behavioral therapy. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1545-50. Epub 2008 Aug 14.

Goode PS, Burgio KL, Kraus SR, Kenton K, Litman HJ, Richter HE; Urinary Incontinence Treatment Network. Correlates and predictors of patient satisfaction with drug therapy and combined drug therapy and behavioral training for urgency urinary incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct. 2011 Mar;22(3):327-34. Epub 2010 Oct 13.

Markland AD, Richter HE, Kenton KS, Wai C, Nager CW, Kraus SR, Xu Y, Tennstedt SL; Urinary Incontinence Treatment Network. Associated factors and the impact of fecal incontinence in women with urge urinary incontinence: from the Urinary Incontinence Treatment Network's Behavior Enhances Drug Reduction of Incontinence study. Am J Obstet Gynecol. 2009 Apr;200(4):424.e1-8. Epub 2009 Feb 6.

Richter HE, Burgio KL, Chai TC, Kraus SR, Xu Y, Nyberg L, Brubaker L. Predictors of outcomes in the treatment of urge urinary incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan 30; [Epub ahead of print]

Zimmern P, Litman HJ, Mueller E, Norton P, Goode P; Urinary Incontinence Treatment Network. Effect of fluid management on fluid intake and urge incontinence in a trial for overactive bladder in women. BJU Int. 2010 Jun;105(12):1680-5. Epub 2009 Nov 13.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dyer KY, Xu Y, Brubaker L, Nygaard I, Markland A, Rahn D, Chai TC, Stoddard A, Lukacz E; Urinary Incontinence Treatment Network (UITN). Minimum important difference for validated instruments in women with urge incontinence. Neurourol Urodyn. 2011 Sep;30(7):1319-24. Epub 2011 May 11.

Responsible Party:	John W. Kusek, PhD- Project Officer, NIDDK
ClinicalTrials.gov Identifier:	NCT00090584 History of Changes
Other Study ID Numbers:	BE-DRI (completed)
Study First Received:	August 27, 2004
Last Updated:	April 25, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Urge urinary incontinence
Drug/Behavior treatment

Additional relevant MeSH terms:

Urinary Incontinence
Urination Disorders
Urologic Diseases
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

ClinicalTrials.gov processed this record on February 12, 2012