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

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
Results First Received: August 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Urinary Incontinence (UI)
Interventions: Drug: Tolterodine
Behavioral: Behavioral training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between July, 2004 and January, 2006 4,043 women were screened for eligibility and 561 provided written consent. After further screening, 134 were found to be ineligible, 119 withdrew consent and 1 was excluded erroneously. The remaining 307 were randomized to one of the treatment arms.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 134 found to be ineligible after consent, for 77 their urinary incontinence (UI) was not urge predominant, 19 had fewer than 7 episodes of incontinence per week and the other 38 were excluded for a variety of reasons.

Reporting Groups
  Description
Combination Therapy Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
Drug Therapy Alone Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.

Participant Flow for 2 periods

Period 1:   Baseline to 10 Weeks
    Combination Therapy   Drug Therapy Alone
STARTED   154   153 
COMPLETED   139   141 
NOT COMPLETED   15   12 
Lost to Follow-up                15                12 

Period 2:   Baseline to 8 Months
    Combination Therapy   Drug Therapy Alone
STARTED   154   153 
COMPLETED   110   112 
NOT COMPLETED   44   41 
Lost to Follow-up                44                41 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Combination Therapy Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
Drug Therapy Alone Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
Total Total of all reporting groups

Baseline Measures
   Combination Therapy   Drug Therapy Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 154   153   307 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   112   106   218 
>=65 years   42   47   89 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.8  (14.2)   58.0  (13.5)   56.9  (13.9) 
Gender 
[Units: Participants]
     
Female   154   153   307 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   154   153   307 


  Outcome Measures
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1.  Primary:   Proportion of Women Who Meet Definition of Success   [ Time Frame: 8 months ]

2.  Secondary:   Change in Incontinence Episodes   [ Time Frame: Baseline and 10 weeks ]

3.  Secondary:   Change in Voids Per Day   [ Time Frame: baseline and 10 weeks ]

4.  Secondary:   Symptom Distress   [ Time Frame: baseline, 10 weeks and 8 months ]

5.  Secondary:   Symptom Bother   [ Time Frame: baseline, 10 weeks and 8 months ]

6.  Secondary:   Satisfaction   [ Time Frame: 10 weeks ]

7.  Secondary:   Satisfaction   [ Time Frame: 8 months ]

8.  Secondary:   Symptom Improvement   [ Time Frame: 10 weeks ]

9.  Secondary:   Symptom Improvement   [ Time Frame: 8 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Ony 68% of participants completed assigned treatment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anne Stoddard, ScD
Organization: New England Research Institutes
phone: 617-972-3331
e-mail: astoddard@neriscience.com


Publications:


Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00090584     History of Changes
Other Study ID Numbers: BE-DRI (completed)
Study First Received: August 27, 2004
Results First Received: August 27, 2012
Last Updated: May 8, 2013