Clinical Trial: Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

This study is currently recruiting patients.

Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

MedlinePlus related topics:  Urinary Incontinence

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Behavior Enhances Drug Reduction of Incontinence

Further Study Details: 

Expected Total Enrollment:  300

Study start: August 2004;  Expected completion: June 2006

Eligibility

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Location and Contact Information

Sharon L Tennstedt, Ph.D.      (617) 923-7747  Ext. 362    sharont@neri.org
Kimberly Dandreo, M.S.      (617) 923-7747  Ext. 219    kdandreo@neri.org

Alabama
      University of Alabama, Birmingham,  Alabama,  35233,  United States; Recruiting
Holly Richter, MD  205-934-7874    hrichter@uabmc.edu 
Alice A Howell, RN  205-975-8592    ahowell@uabmc.edu 
Holly Richter, MD,  Principal Investigator
L. Keith Lloyd, MD,  Sub-Investigator
Rowell Ashford, MD,  Sub-Investigator
Kathryn Burgio, PhD,  Sub-Investigator
Seine Chiang, MD,  Sub-Investigator
Patricia S. Goode, MD,  Sub-Investigator
Lee Hammontree, MD,  Sub-Investigator
R. Edward Varner, MD,  Sub-Investigator

California
      University of California, San Diego,  California,  92103,  United States; Recruiting
Michael Albo, MD  858-657-8435    malbo@ucsd.edu 
D. Lynn Kalinoski, PhD  619-543-2169    dkalinos@ucsd.edu 
Michael Albo, MD,  Principal Investigator
Charles Nager, MD,  Sub-Investigator
Christine Dorr, MD,  Sub-Investigator
Karl M. Luber, MD,  Sub-Investigator
Emily Lukacz, MD,  Sub-Investigator
Amanda Simsiman, MD,  Sub-Investigator

Illinois
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States; Recruiting
Linda Brubaker, MD  708-216-2170    lbrubaker@lumc.edu 
Kathy Jesse, RN  708-216-8944    kjesse1@lumc.edu 
Linda Brubaker, M.D,  Principal Investigator
MaryPat Fitzgerald, MD,  Sub-Investigator
Kimberly Kenton, MD,  Sub-Investigator

Maryland
      University of Maryland, Baltimore,  Maryland,  21201,  United States; Recruiting
Toby Chai, MD  410-328-5544    tchai@smail.umaryland.edu 
Judith Murray, CCRC  410-328-5784    jmurray@smail.umaryland.edu 
Toby Chai, MD,  Principal Investigator
Harry Johnson, MD,  Sub-Investigator

Michigan
      Oakwood Hospital and Medical Center, Royal Oak,  Michigan,  48123,  United States; Recruiting
Veronica Mallett, MD  313-436-2201    mallettv@oakwood.org 
Kathryn Koches, RN  313-436-2242    kochesk@oakwood.org 
Ananias C Diokno, MD,  Principal Investigator
Veronica Mallett, MD,  Sub-Investigator
Salil Khandwala, MD,  Sub-Investigator

Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Halina Zyczynski, MD  412-641-1440    hzyczynski@mail.magee.edu 
Judith Gruss, RN  412-641-5388    jgruss@mail.magee.edu 
Halina Zyczynski, MD,  Principal Investigator
Wendy Leng, MD,  Sub-Investigator
Pamela A Moalli, MD,  Sub-Investigator
Elizabeth Sagan, MD,  Sub-Investigator

Texas
      University of Texas Southwestern, Dallas,  Texas,  75390,  United States; Recruiting
Philippe Zimmern, MD  214-648-9397    philippe.zimmern@utsouthwestern.edu 
Norma Pope, RN, WHNP  214-645-8791    norma.pope@utsouthwestern.edu 
Philippe Zimmern, MD,  Principal Investigator
Gary E. Lemack, MD,  Sub-Investigator
Muriel Boreham, MD,  Sub-Investigator
Mikio Nihira, MD, MPH,  Sub-Investigator
Joseph Schaffer, MD,  Sub-Investigator
Clifford Wai, MD,  Sub-Investigator

      University of Texas Health Sciences Center, San Antonio,  Texas,  78229,  United States; Recruiting
Stephen Kraus, MD  210-567-5650    krauss@uthscsa.edu 
Sylvia Escobedo Sluder, CCRP  210-567-0550    sluder@uthscsa.edu 
Stephen Kraus, MD,  Principal Investigator
Ash Dabbous, MD,  Sub-Investigator
Alayne Markland, DO,  Sub-Investigator

Utah
      University of Utah, Salt Lake City,  Utah,  84132,  United States; Recruiting
Peggy Norton, MD  801-581-3565    peggy.norton@hsc.utah.edu 
Shelly O'Meara, RN  801-581-6874    shelly.omeara@hsc.utah.edu 
Peggy Norton, MD,  Principal Investigator
Lindsey Kerr, MD,  Sub-Investigator
Jan Baker, APRN,  Sub-Investigator
David Lesser, MD,  Sub-Investigator

Study chairs or principal investigators

William D Steers, M.D.,  Study Chair,  University of Virginia   

More Information

www.uitn.net

Study ID Numbers:  BE-DRI
Record last reviewed:  February 2005
Last Updated:  February 7, 2005
Record first received:  August 27, 2004
ClinicalTrials.gov Identifier:  NCT00090584
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005