Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy (Hyp-hOP)
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.
Urinary Incontinence, Urge
Drug: Anticholinergic medications
|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|
- 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
- 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
|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)|
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.
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01829425
|Contact: Yuko Komesu, MDfirstname.lastname@example.org|
|Contact: Loren Ketai, MDemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Loren Ketai, MD 505-272-2269 email@example.com|
|Principal Investigator: Yuko Komesu, MD|
|Principal Investigator:||Yuko Komesu, MD||University of New Mexcio Health Science Center|