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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of New Mexico
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01829425
First received: April 8, 2013
Last updated: June 9, 2016
Last verified: June 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    UUI cure, as defined as absence of urgency incontinence episodes on voiding diaries, will be assessed at 2,6, and 12 month follow-up


Estimated Enrollment: 185
Study Start Date: March 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 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.

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  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829425

Contacts
Contact: Yuko Komesu, MD 505-272-9702 ykomesu@salud.unm.edu
Contact: Loren Ketai, MD 505-272-2269 lketai@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Health Science Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Yuko Komesu, MD    505-272-9712    ykomesu@salud.unm.edu   
Contact: Loren Ketai, MD    505-272-2269    lketai@salud.unm.edu   
Principal Investigator: Yuko Komesu, MD         
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  1R01AT007171-01A1 
Study First Received: April 8, 2013
Last Updated: June 9, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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

ClinicalTrials.gov processed this record on July 25, 2016