Hypnotherapy for Treatment of Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuko Komesu, University of New Mexico
ClinicalTrials.gov Identifier:
NCT00793611
First received: October 6, 2008
Last updated: September 20, 2011
Last verified: September 2011
Results First Received: August 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Overactive Bladder
Interventions: Behavioral: Behavioral therapy standard of care
Other: hypnotherapy

  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
Patients recruited from the Clinic. Study received IRB approval winter 2008 and recruitment occurred 2008-10.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Behavioral Therapy Standard Care received 3 behavioral therapy session
Hypnotherapy received 3 sessions of behavioral therapy combined with hypnotherapy

Participant Flow:   Overall Study
    Behavioral Therapy Standard Care     Hypnotherapy  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Behavioral Therapy Standard Care received 3 behavioral therapy session
Hypnotherapy received 3 sessions of behavioral therapy combined with hypnotherapy
Total Total of all reporting groups

Baseline Measures
    Behavioral Therapy Standard Care     Hypnotherapy     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: years]
Mean ± Standard Deviation
  56.4  ± 7.4     51.1  ± 14     54  ± 11  
Gender  
[units: participants]
     
Female     10     10     20  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures
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1.  Primary:   Change in Overactive Bladder Symptoms (Based on OABqSF)   [ Time Frame: baseline and approximately 6-12 weeks after study initiation ]

2.  Secondary:   Change in Voiding Frequency Based on Voiding Diary   [ Time Frame: baseline and 6-12 weeks after study initiation ]

3.  Secondary:   Patient Global Impression of Improvement   [ Time Frame: 6-12 weeks after study initiation (@ completion of intervention) ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Yuko Komesu MD
Organization: University of New Mexico Health Sciences Center and CTSC
phone: 505-925-4395
e-mail: ykomesu@salud.unm.edu


Publications of Results:

Responsible Party: Yuko Komesu, University of New Mexico
ClinicalTrials.gov Identifier: NCT00793611     History of Changes
Other Study ID Numbers: 08-102
Study First Received: October 6, 2008
Results First Received: August 16, 2011
Last Updated: September 20, 2011
Health Authority: United States: Institutional Review Board