Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00090584
First received: August 27, 2004
Last updated: May 8, 2013
Last verified: May 2013

August 27, 2004
May 8, 2013
August 2004
December 2005   (final data collection date for primary outcome measure)
Proportion of Women Who Meet Definition of Success [ Time Frame: 8 months ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00090584 on ClinicalTrials.gov Archive Site
  • Change in Incontinence Episodes [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.
  • Change in Voids Per Day [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary
  • Symptom Distress [ Time Frame: baseline, 10 weeks and 8 months ] [ Designated as safety issue: No ]
    Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.
  • Symptom Bother [ Time Frame: baseline, 10 weeks and 8 months ] [ Designated as safety issue: No ]
    Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.
  • Satisfaction [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"
  • Satisfaction [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"
  • Symptom Improvement [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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?"
Not Provided
Not Provided
Not Provided
 
Behavior Enhances Drug Reduction of Incontinence (BE-DRI)
Behavior Enhances Drug Reduction of Incontinence

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Incontinence (UI)
  • 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.
  • Experimental: Combination therapy
    Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training.
    Interventions:
    • Drug: Tolterodine
    • Behavioral: Behavioral training
  • Active Comparator: Drug therapy alone
    Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.
    Intervention: Drug: Tolterodine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
307
August 2006
December 2005   (final data collection date for primary outcome measure)

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
Female
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00090584
BE-DRI (completed)
Yes
New England Research Institutes
New England Research Institutes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: William D Steers, M.D. University of Virginia
New England Research Institutes
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP