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Completed

NCT Number: NCT00090584

Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

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.

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Key information

Conditions

Urinary Incontinence (UI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tolterodine

Drug

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

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.

Primary outcomes

  1. Proportion of Women Who Meet Definition of Success

    Time frame: 8 months

    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 outcomes

  1. Change in Incontinence Episodes

    Time frame: Baseline and 10 weeks

    Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.

  2. Change in Voids Per Day

    Time frame: baseline and 10 weeks

    Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary

  3. Symptom Distress

    Time frame: baseline, 10 weeks and 8 months

    Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.

  4. Symptom Bother

    Time frame: baseline, 10 weeks and 8 months

    Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.

  5. Satisfaction

    Time frame: 10 weeks

    Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"

  6. Satisfaction

    Time frame: 8 months

    Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"

  7. Symptom Improvement

    Time frame: 10 weeks

    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. Symptom Improvement

    Time frame: 8 months

    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?"

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Behavior Enhances Drug Reduction of Incontinence

Acronym: BE-DRI

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Aug 31, 2004
Registry last updated
Jun 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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