Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

NCT00090584 | Completed Results DMC

• 1 other identifier: BE-DRI (completed)
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 9

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.

Conditions

Urinary Incontinence (UI)

Keywords

Urge urinary incontinence (UUI); Drug/Behavior treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months

Secondary Outcomes (8)

• Change in Incontinence Episodes

  Baseline and 10 weeks

• Change in Voids Per Day

  baseline and 10 weeks

• Symptom Distress

  baseline, 10 weeks and 8 months

• Symptom Bother

  baseline, 10 weeks and 8 months

• Satisfaction

  10 weeks

Study Arms (2)

Combination therapy

EXPERIMENTAL

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

Drug: Tolterodine; Behavioral: Behavioral training

Drug therapy alone

ACTIVE COMPARATOR

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

Drug: Tolterodine

Interventions

Tolterodine DRUG

4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.

Combination therapy; Drug therapy alone

Behavioral training BEHAVIORAL

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.

Combination therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Urge predominant incontinence
• Incontinent \> 3 mos
• Available for 8 mos of followup

You may not qualify if:

• 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

Sponsors & Collaborators

• Carelon Research: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (9)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

University of California

San Diego, California, 92103, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Oakwood Hospital and Medical Center

Royal Oak, Michigan, 48123, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Health Sciences Center

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (13)

• 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.

  PMID: 16919506 BACKGROUND

• 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.

  PMID: 20671098 BACKGROUND

• 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.

  PMID: 21181960 BACKGROUND

• 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.

  PMID: 20143047 BACKGROUND

• 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.

  PMID: 18678843 BACKGROUND

• 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.

  PMID: 18704249 BACKGROUND

• 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.

  PMID: 20945064 BACKGROUND

• 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.

  PMID: 19200939 BACKGROUND

• 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.

  PMID: 19183825 BACKGROUND

• 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.

  PMID: 19912207 BACKGROUND

• 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.

  PMID: 22453106 BACKGROUND

• 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.

  PMID: 21563210 BACKGROUND

• Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

  PMID: 37811598 DERIVED

Related Links

• www.uitn.net

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Urge

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Limitations and Caveats

Ony 68% of participants completed assigned treatment.

Results Point of Contact

• Title: Anne Stoddard, ScD
• Organization: New England Research Institutes

astoddard@neriscience.com

617-972-3331

Study Officials

• William D Steers, M.D.

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2004
• First Posted: August 31, 2004
• Study Start: August 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: August 1, 2006
• Last Updated: June 17, 2013
• Results First Posted: June 17, 2013

Record last verified: 2013-05

Locations

US (9)