Hypnotherapy for Treatment of Overactive Bladder

NCT00793611 | Completed Results DMC

• 1 other identifier: 08-102
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Overactive Bladder

Keywords

Overactive Bladder; Hypnotherapy

Outcome Measures

Primary Outcomes (1)

• Change in Overactive Bladder Symptoms (Based on OABqSF)

  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.

  baseline and approximately 6-12 weeks after study initiation

Secondary Outcomes (2)

• Change in Voiding Frequency Based on Voiding Diary

  baseline and 6-12 weeks after study initiation

• Patient Global Impression of Improvement

  6-12 weeks after study initiation (@ completion of intervention)

Study Arms (2)

Behavioral therapy

ACTIVE COMPARATOR

"Behavioral Therapy standard of care (which consists of bladder drills, voiding diaries, timed voiding and pelvic floor exercises)"

Behavioral: Behavioral therapy standard of care

hypnotherapy

EXPERIMENTAL

patients will receive 3 hypnotherapy sessions in addition to usual behavioral treatments for overactive bladder

Behavioral: Behavioral therapy standard of care; Other: hypnotherapy

Interventions

Behavioral therapy standard of care BEHAVIORAL

controls will receive usual interventions for overactive bladder: voiding diary, bladder drills, pelvic floor exercises

Also known as: behavioral treatment, pelvic floor exercise, bladder drills

Behavioral therapy; hypnotherapy

hypnotherapy OTHER

Patients will receive 3 hypnotherapy sessions in addition to usual behavioral treatment of overactive bladder

Also known as: hypnosis

hypnotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Less than 18 years old
• History of Schizophrenia or Bipolar Disorder

Sponsors & Collaborators

• University of New Mexico: lead

Related Publications (1)

• Freeman RM, Baxby K. Hypnotherapy for incontinence caused by the unstable detrusor. Br Med J (Clin Res Ed). 1982 Jun 19;284(6332):1831-4. doi: 10.1136/bmj.284.6332.1831.

  PMID: 6805716 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Behavior Therapy; Hypnosis

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Yuko Komesu MD
• Organization: University of New Mexico Health Sciences Center and CTSC

ykomesu@salud.unm.edu

505-925-4395

Study Officials

• Yuko M Komesu, MD

  University of New Mexico Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Ob-Gyn University of new Mexico

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 9, 2017
• Results First Posted: October 28, 2011

Record last verified: 2017-09