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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01829425
First Posted: April 11, 2013
Last Update Posted: August 22, 2017
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.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of New Mexico
  Purpose

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; a subset of women will have pre-treatment brain activation and connectivity compared to controls using functional magnetic imaging (fMRI) with 2 month post-treatment brain activation and connectivity compared to pre-treatment in the UUI subset using fMRI.

Hypotheses: Among patients with urgency urinary incontinence (UUI), hypnotherapy decreases abnormal perception of bladder distension outside the hypnotic state and is at least as effective as pharmacotherapy in diminishing symptoms of urgency and severity of UUI. On fMRI in UUI, hypnotherapy will decrease hyper-activation of brain areas in response to bladder distension and/or modulate functional connectivity within the brain. Normalization of hyper-activation and connectivity will be greater in hypnotherapy compared to pharmacotherapy. Additionally, women who have greater improvement in UUI will have greater normalization of hyper-activation and connectivity on fMRI. UUI participants will exhibit increased activation within portions of the brain and abnormal functional connectivity relative to controls.


Condition Intervention
Urinary Incontinence, Urge Drug: Anticholinergic medications Behavioral: Hypnotherapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Change in urgency urinary incontinence on diary and functional magnetic resonance imaging [ Time Frame: Baseline and 2 month follow-up ]
    UUrgency Urinary Incontinence episodes recorded on voiding diaries at initial follow-up in participants who have undergone pharmacotherapy versus hypnotherapy and evoked brain activation and resting connectivity on functional MRI at initial follow-up relative to pretreatment


Secondary Outcome Measures:
  • Urinary urge incontinence episodes recorded on voiding diaries at later follow-up [ Time Frame: 6 & 12 months post treatment ]
    Between group comparisons of Post-treatment change in urgency urinary incontinence from baseline to episodes recorded on voiding diaries after 2 month follow-up

  • Questionnaire scores [ Time Frame: Baseline and 2, 6 and 12 months post treatment ]
    Between and within group comparisons of Pre and Post-treatment expectation questions and change in baseline and post-treatment questionnaires(Overactive Bladder Questionnaire Short Form/OAB-q SF, Incontinence Severity Index/ISI, Patient Perception Bladder Condition/PPBC, Pelvic Organ Prolapse Incontinence Questionnaire 12/PISQ-12--see study design)scores

  • urinary frequency and pad counts [ Time Frame: Baseline and 2,6,12 months post treatment ]
    change in voiding frequency and pad counts on voiding diary

  • Irritable bowel syndrome and bowel symptoms and/or Painful Bladder/Interstitial Cystitis in this population [ Time Frame: Baseline and 2,6,12 months post-treatment ]
    Describe prevalence of irritable bowel syndrome and bowel symptoms as well as painful bladder/interstitial cystitis based on patient history and questionnaires (Colo-rectal anal distress inventory-8/CRADI-8, IBS Module, Bladder Pain Interstitial Cystitis Symptom Score/BPIC-SS, Visual Analogue Pain Scale) in this population and (if these are prevalent) describe changes in the questionnaires following treatment

  • Evoked brain activation and resting connectivity on functional MRI [ Time Frame: Baseline ]
    Comparison of baseline fMRI evaluation of UUI subjects and unaffected controls with respect to evoked brain activation in the limbic cortex in response to urinary bladder distension and in respect to limbic system resting connectivity.

  • Urgency urinary incontinence cure [ Time Frame: 2, 6 and 12 month follow-up ]
    UUI cure, as defined as absence of urgency incontinence episodes on voiding diaries, will be assessed at 2,6, and 12 month follow-up


Enrollment: 196
Study Start Date: March 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:(For RCT)

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

Exclusion Criteria: (For RCT)

  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.
  Contacts and Locations
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
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
Principal Investigator: Yuko Komesu, MD University of New Mexcio Health Science Center
  More Information

Publications:

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01829425     History of Changes
Other Study ID Numbers: R01AT007171 ( U.S. NIH Grant/Contract )
1R01AT007171-01A1 ( U.S. NIH Grant/Contract )
First Submitted: April 8, 2013
First Posted: April 11, 2013
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University of New Mexico:
Hypnosis
Mind-Body Therapy
Anticholinergics
fMRI
Functional Neuroimaging
Gyrus Cinguli
Female Urogenital Diseases

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
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