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Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy (Hyp-hOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829425
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : April 1, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Yuko Komesu, University of New Mexico

Brief Summary:
This study is randomized controlled trial in which urgency incontinent women (approximately 150-160) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6 &12 Hypotheses: Among patients with urgency urinary incontinence (UUI), hypnotherapy will be non-inferior pharmacotherapy in diminishing UUI episodes. Hypnotherapy may be superior or may not differ from pharmacotherapy in diminishing symptoms or quality of life based on validated questionnaires and/or other diary parameters.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Urge Drug: Anticholinergic medications Behavioral: Hypnotherapy Not Applicable

Detailed Description:

Study Objectives Primary: To compare change in Urgency Urinary Incontinence (UUI) episodes at 2 month follow-up on voiding diaries between hypnotherapy and pharmacotherapy groups (to determine whether hypnotherapy is at least as effective and durable in treating UUI as pharmacotherapy)

Secondary Analyses:

  • To determine whether hypnotherapy is at least as effective in treating UUI as pharmacotherapy comparing change in UUI episodes on voiding diary at 6 and 12 month follow-up
  • To determine whether hypnotherapy differs from pharmacotherapy in treating UUI comparing change in questionnaire results and urinary frequency
  • enrolled following administration of the Overactive Bladder (OAB) Awareness tool. Participants will keep voiding diaries then be randomized to either pharmacotherapy and conventional behavioral therapy or hypnotherapy and conventional behavioral therapy. Approximately 150-160 women will be randomized.

Randomization will occur using a computer-generated randomization scheme in varying permuted block sizes. Study personnel performing data entry will be masked to participants' treatment. Masking participants to treatment is not feasible. Participants will be followed at 2,6 & 12 months. Measurements will be performed before treatment, following completion of treatment visits (approximately 8 weeks), and at 6 and 12 months. Primary analysis will be intention to treat. Exploratory analyses of secondary outcomes will also be performed.

Study Visits: UUI participant screening: Study information given. Screening questionnaire given. Visit 1 Enrollment: Formal screening for eligibility, voiding diary reviewed, if eligible, written consent obtained with administration of study questionnaires, demographic and past medical history administration forms, Pelvic Organ Prolapse Quantitation (POP-Q) exam & hypnotic susceptibility testing scheduled. Pariticipants undergo hypnotic susceptibility testing prior to randomization. Participants randomized to treatment and contacted, treatments arranged. Hypnotherapy group: undergo weekly treatments over 8 weeks. Pharmacotherapy group: weekly counseling sessions over 8 week: Following hypnotherapy or medication counseling completion, f/u voiding diaries collected & study questionnaires administered. One of two long acting anti-cholinergic medications offered (Long acting Tolterodine or Extended Release Oxybutynin or equivalent generic substitutes).

6 & 12 month follow-up: Pharmacotherapy subjects receive medications for 1 year and Hypnotherapy subjects encouraged to continue self-hypnosis for 1 year with assistance of audio-recordings, with 1 optional hypnotherapy session between 6-12 months..

Participants informed pharmacotherapy & hypnotherapy sessions are audio-recorded and reviewed ensuring manual of procedures are followed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Protocol for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence An RCT: Hypnotherapy Or Pharmacotherapy
Actual Study Start Date : April 22, 2013
Actual Primary Completion Date : October 27, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Anticholinergic medications
Either of two standard, long acting anti-cholinergic medications (Long acting Tolterodine or Extended Release Oxybutynin)will be given. Subjects receive 8 weeks of medication counseling in conjunction with the medications. Medications will be continued for 1 year.
Drug: Anticholinergic medications
The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
Other Names:
  • Tolterodine (Detrol LA or equivalent generic)
  • Oxybutynin (Ditropan Extended Release or equivalent generic)

Active Comparator: Hypnotherapy
Subjects will receive approximately weekly hypnotherapy sessions over 8 weeks and will receive/download digital recordings for home practice. Subjects will be encouraged to practice self-hypnosis +/or listen to their recordings for 1 year.
Behavioral: Hypnotherapy
Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.




Primary Outcome Measures :
  1. Percent Change in Urgency Urinary Incontinence Episodes [ Time Frame: Baseline and 2 month follow-up ]
    Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy & pharmacotherapy


Secondary Outcome Measures :
  1. Percent Change in Urgency Urinary Incontinence Episodes [ Time Frame: 6 months ]
    Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes

  2. Percent Change in Urgency Urinary Incontinence Episodes [ Time Frame: 12 months ]
    Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy & pharmacotherapy

  3. Overactive Bladder Questionnaire Short Form Symptom Bother [ Time Frame: 2 months ]
    Overactive Bladder Questionnaire Short Form symptom bother Scale. Sub-Scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother)

  4. Overactive Bladder Questionnaire Short Form Symptom Bother [ Time Frame: 6 months ]
    Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother)

  5. Overactive Bladder Questionnaire Short Form Symptom Bother [ Time Frame: 12 months ]
    Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother)

  6. Overactive Bladder Questionnaire Short Form Quality of Life [ Time Frame: 2 months ]
    Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-score range 0-100.

  7. Overactive Bladder Questionnaire Short Form Quality of Life [ Time Frame: 6 months ]
    Overactive Bladder questionnaire Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-scale score range 0-100.

  8. Overactive Bladder Questionnaire Short Form Quality of Life [ Time Frame: 12 months ]
    Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (higher quality of life) and lower scores are worse (poorer quality of life). score range 0-100.

  9. Voids on Bladder Diary [ Time Frame: 2 months ]
    Total Number of voids on 3-day bladder diary.

  10. Voids on Bladder Diary [ Time Frame: 6 months ]
    number of voids on 3-day bladder diary

  11. Voids on Bladder Diary [ Time Frame: 12 months ]
    number of voids on 3-day bladder diary



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:(For randomized trial)

  1. Non-pregnant English-speaking women
  2. 18 yo or older
  3. Overactive Bladder (OAB) Awareness scores ≥ 8
  4. 3 UUI episodes/week for ≥ 3 months

Exclusion Criteria: (For Randomized trial)

  1. Women with a history of neurologic diseases such as Multiple Sclerosis, Parkinson's disease, stroke, or dementia
  2. History of schizophrenia or untreated bipolar disorder or current drug or alcohol dependence
  3. Women who have taken anticholinergic medications for UUI within the last 3 weeks (women who have taken anti-cholinergics for UUI but discontinued them > than 3 weeks ago may participate in the study) or have a sacral neuromodulator in place to treat UUI or have received Onabotulinum toxin A in the last 12 months to treat UUI
  4. Contraindications to anticholinergic medications (untreated narrow angle glaucoma, significant urinary retention or gastric retention)
  5. Pregnant women or lactating women, women who plan to become pregnant in the next year, or pre-menopausal women unwilling to use contraception if engaging in sexual relations during the year of study participation (hysterectomy is considered to be a form of contraception)
  6. Untreated urinary tract infection
  7. Prolapse which extends past the hymen (POP-Q points of ≥ 1+) which may be responsible for UUI symptoms
  8. Women who cannot keep the majority of the study therapy appointments or those without reliable contact phone numbers or methods of communication with the study personnel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829425


Locations
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United States, New Mexico
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Yuko Komesu, MD University of New Mexcio Health Science Center
  Study Documents (Full-Text)

Documents provided by Yuko Komesu, University of New Mexico:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuko Komesu, MD, University of New Mexico
ClinicalTrials.gov Identifier: NCT01829425    
Other Study ID Numbers: 09-314
1R01AT007171-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2013    Key Record Dates
Results First Posted: April 1, 2019
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The information will be shared with other researchers upon their request. Our IRB required that we re-consent participants in order to make their data available to others. We can only share the information available on participants who signed these additional consents.
Supporting Materials: Study Protocol
Time Frame: 6 months after manuscript for the primary outcome is accepted for publication. Anticipated time for manuscript acceptance July 2019. Anticipated availability 3-5 years.
Access Criteria: Dr. Komesu and Dr. Ketai will review requests. Access criteria includes de-identified dataset (including de-identification of dates of visit as this may be interpreted as a potential identifier) of those who consented to have data shared. Data for secondary manuscripts in progress by PIs will be shared only after PIs publish said data 6 months post-publication.
Keywords provided by Yuko Komesu, University of New Mexico:
Hypnosis
Mind-Body Therapy
Anticholinergics
Female Urogenital Diseases
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Tolterodine Tartrate
Oxybutynin
Cholinergic Antagonists
Muscarinic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents