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Hypnotherapy for Treatment of Overactive Bladder
This study is currently recruiting participants.
Verified by University of New Mexico, October 2008
Sponsored by: University of New Mexico
Information provided by: University of New Mexico
ClinicalTrials.gov Identifier: NCT00793611
  Purpose

The investigators purpose is to perform a pilot study evaluating the efficacy in hypnotherapy in treating women with Overactive Bladder Symptoms (urinary urgency symptoms and urinary frequency). Approximately half the women in the study will receive "standard care" (performing a voiding diary, Pelvic Floor exercises, and timed voiding) and the other half will receive "standard care" and 3 hypnotherapy sessions. The investigators will compare the groups using a validated overactive bladder questionnaire and compare voiding diaries to evaluate urinary frequency at the end of the sessions/study completion.


Condition Intervention Phase
Overactive Bladder
Behavioral: control group
Other: hypnotherapy
Phase II
Phase III

MedlinePlus related topics: Exercise and Physical Fitness Pelvic Support Problems Urine and Urination
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Hypnotherapy for Treatment of Overactive Bladder: A Feasibility Study

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Change in Overactive Bladder Symptoms (based on validated questionnaire) [ Time Frame: approximate 6-12 weeks after study initation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in voiding frequency based on voiding diary [ Time Frame: 6-12 weeks after study initiation ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control group: Active Comparator
patients will receive usual overactive bladder treatments; bladder drills, voiding diary and pelvic floor exercises
Behavioral: control group
controls will receive usual interventions for overactive bladder: voiding diary, bladder drills, pelvic floor exercises
hypnotherapy: Experimental
patients will receive 3 hypnotherapy sessions in addition to usual treatments for overactive bladder
Other: hypnotherapy
Patients will receive 3 hypnotherapy sessions in addition to usual treatment of overactive bladder

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • More than 8 voids/day
  • Score > 8 on OABq questionnaire
  • English speaking

Exclusion Criteria:

  • Pregnancy
  • Less than 18 years old
  • History of Schizophrenia or Bipolar Disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793611

Contacts
Contact: Yuko m Komesu, MD 505-272-9702 ykomesu@salud.unm.edu
Contact: Rebecca m Rogers, MD 505-272-9712 rrogers@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico HRRC & Dept OBGYN Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Yuko M Komesu, MD     505-272-9702     ykomesu@salud.unm.edu    
Principal Investigator: Yuko M Komesu, MD            
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Yuko M Komesu, MD University of New Mexico Health Sciences Center
  More Information

Publications of Results:
Responsible Party: University of new mexico Health sciences center dept. Ob-Gyn ( Yuko Komesu MD )
Study ID Numbers: 08-102
Study First Received: October 6, 2008
Last Updated: November 18, 2008
ClinicalTrials.gov Identifier: NCT00793611  
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Overactive Bladder
Hypnotherapy

Study placed in the following topic categories:
Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:
Urological Manifestations

ClinicalTrials.gov processed this record on January 15, 2009