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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
History of Changes
  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: Behavioral therapy standard of care
Other: hypnotherapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypnotherapy for Treatment of Overactive Bladder: A Feasibility Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Change in Overactive Bladder Symptoms (Based on OABqSF) [ Time Frame: baseline and approximately 6-12 weeks after study initiation ] [ Designated as safety issue: No ]
    Scale information; Score ranges for oab-qsf quality of life scores range from 13-78; 13=poor quality of life 78=good quality of life. We reported change scores, with larger negative numbers indicating greater improvement in quality of life scores.


Secondary Outcome Measures:
  • Change in Voiding Frequency Based on Voiding Diary [ Time Frame: baseline and 6-12 weeks after study initiation ] [ Designated as safety issue: No ]
    change in mean number of voids per 24 hours. Each participant recorded voiding frequency every 24 hours for 3 days at baseline and follow-up. A mean number of voids for every patient over 24 hours was calculated at baseline and follow-up.

  • Patient Global Impression of Improvement [ Time Frame: 6-12 weeks after study initiation (@ completion of intervention) ] [ Designated as safety issue: No ]
    Outcome measure is only administered at follow-up and used following treatment in patients with urinary incontinence. Measure varies from 1 to 7 on a Likert scale. 1=very much better and 7=very much worse and 4=no change. Thus, lower numbers represent greater improvement.


Enrollment: 20
Study Start Date: November 2008
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Behavioral therapy
"Behavioral Therapy standard of care (which consists of bladder drills, voiding diaries, timed voiding and pelvic floor exercises)"
 Behavioral: Behavioral therapy standard of care
controls will receive usual interventions for overactive bladder: voiding diary, bladder drills, pelvic floor exercises
Other Names:
  • behavioral treatment
  • pelvic floor exercise
  • bladder drills
Experimental: hypnotherapy
patients will receive 3 hypnotherapy sessions in addition to usual behavioral treatments for overactive bladder
 Behavioral: Behavioral therapy standard of care
controls will receive usual interventions for overactive bladder: voiding diary, bladder drills, pelvic floor exercises
Other Names:
  • behavioral treatment
  • pelvic floor exercise
  • bladder drills
Other: hypnotherapy
Patients will receive 3 hypnotherapy sessions in addition to usual behavioral treatment of overactive bladder
Other Name: hypnosis

  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

Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Yuko M Komesu, MD University of New Mexico Health Sciences Center
  More Information

Publications:

Responsible Party: Yuko Komesu, Assistant Professor Ob-Gyn University of new Mexico, 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

Keywords provided by University of New Mexico:
Overactive Bladder
Hypnotherapy

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013