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Behavior Enhances Drug Reduction of Incontinence (BE-DRI) (BE-DRI)

Primary Purpose

Urinary Incontinence (UI)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tolterodine
Behavioral training
Sponsored by
Carelon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence (UI) focused on measuring Urge urinary incontinence (UUI), Drug/Behavior treatment

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama
  • University of California
  • Loyola University Medical Center
  • University of Maryland
  • Oakwood Hospital and Medical Center
  • University of Pittsburgh
  • University of Texas Southwestern
  • University of Texas Health Sciences Center
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination therapy

Drug therapy alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of Women Who Meet Definition of Success
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
Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.
Change in Voids Per Day
Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary
Symptom Distress
Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.
Symptom Bother
Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.
Satisfaction
Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"
Satisfaction
Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"
Symptom Improvement
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
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?"

Full Information

First Posted
August 27, 2004
Last Updated
May 8, 2013
Sponsor
Carelon Research
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00090584
Brief Title
Behavior Enhances Drug Reduction of Incontinence (BE-DRI)
Acronym
BE-DRI
Official Title
Behavior Enhances Drug Reduction of Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carelon Research
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence (UI)
Keywords
Urge urinary incontinence (UUI), Drug/Behavior treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination therapy
Arm Type
Experimental
Arm Description
Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
Arm Title
Drug therapy alone
Arm Type
Active Comparator
Arm Description
Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.
Intervention Type
Drug
Intervention Name(s)
Tolterodine
Intervention Description
4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral training
Intervention 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.
Primary Outcome Measure Information:
Title
Proportion of Women Who Meet Definition of Success
Description
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.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Change in Incontinence Episodes
Description
Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.
Time Frame
Baseline and 10 weeks
Title
Change in Voids Per Day
Description
Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary
Time Frame
baseline and 10 weeks
Title
Symptom Distress
Description
Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.
Time Frame
baseline, 10 weeks and 8 months
Title
Symptom Bother
Description
Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.
Time Frame
baseline, 10 weeks and 8 months
Title
Satisfaction
Description
Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"
Time Frame
10 weeks
Title
Satisfaction
Description
Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"
Time Frame
8 months
Title
Symptom Improvement
Description
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?"
Time Frame
10 weeks
Title
Symptom Improvement
Description
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?"
Time Frame
8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D Steers, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oakwood Hospital and Medical Center
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48123
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16919506
Citation
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. doi: 10.1016/j.cct.2006.06.002. Epub 2006 Jun 18.
Results Reference
background
PubMed Identifier
20671098
Citation
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. doi: 10.2522/ptj.20080387. Epub 2010 Jul 29.
Results Reference
background
PubMed Identifier
21181960
Citation
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. doi: 10.1002/nau.20922.
Results Reference
background
PubMed Identifier
20143047
Citation
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. 2010 Jun;21(6):711-9. doi: 10.1007/s00192-010-1100-x. Epub 2010 Feb 9.
Results Reference
background
PubMed Identifier
18678843
Citation
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. doi: 10.7326/0003-4819-149-3-200808050-00005.
Results Reference
background
PubMed Identifier
18704249
Citation
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. doi: 10.1007/s00192-008-0687-7. Epub 2008 Aug 14.
Results Reference
background
PubMed Identifier
20945064
Citation
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. 2011 Mar;22(3):327-34. doi: 10.1007/s00192-010-1287-x. Epub 2010 Oct 13.
Results Reference
background
PubMed Identifier
19200939
Citation
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. doi: 10.1016/j.ajog.2008.11.023. Epub 2009 Feb 6.
Results Reference
background
PubMed Identifier
19183825
Citation
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 May;20(5):489-97. doi: 10.1007/s00192-009-0805-1. Epub 2009 Jan 30.
Results Reference
background
PubMed Identifier
19912207
Citation
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. doi: 10.1111/j.1464-410X.2009.09055.x. Epub 2009 Nov 13.
Results Reference
background
PubMed Identifier
22453106
Citation
Fitzgerald MP, Dubeau CE, Kraus SR, Johnson HW Jr, Rahn DD, Mallett V, Stoddard AM, Zyczynski HM; Urinary Incontinence Treatment Network. Patient expectations did not predict outcome of drug and behavioral treatment of urgency urinary incontinence. Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):231-7. doi: 10.1097/SPV.0b013e31822dd10b.
Results Reference
background
PubMed Identifier
21563210
Citation
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. doi: 10.1002/nau.21028. Epub 2011 May 11.
Results Reference
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Links:
URL
http://www.uitn.net
Description
www.uitn.net

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Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

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