Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

Urinary Incontinence (UI) Clinical Trial

— BE-DRI  

Official title:

Behavior Enhances Drug Reduction of Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090584
• Other study ID #: BE-DRI (completed)
• Status: Completed
• Phase: N/A
• First received: August 27, 2004
• Last updated: May 8, 2013
• Start date: August 2004
• Est. completion date: August 2006

Study information

• Verified date: May 2013
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: August 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence (UI)

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	University of Texas Southwestern	Dallas	Texas
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oakwood Hospital and Medical Center	Royal Oak	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Sciences Center	San Antonio	Texas
United States	University of California	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
New England Research Institutes	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2006 Jun 18. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Incontinence Episodes	Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.	Baseline and 10 weeks	No
Secondary	Change in Voids Per Day	Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary	baseline and 10 weeks	No
Secondary	Symptom Distress	Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.	baseline, 10 weeks and 8 months	No
Secondary	Symptom Bother	Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.	baseline, 10 weeks and 8 months	No
Secondary	Satisfaction	Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"	10 weeks	No
Secondary	Satisfaction	Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"	8 months	No
Secondary	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?"	10 weeks	No
Secondary	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?"	8 months	No