Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy (Hyp-hOP)
This study includes:
A trial in which urge incontinent women (N=152) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6 &12.
- The primary objective will be change in Urgency Urinary Incontinence (UUI) episodes.
Secondary objectives will; be change in subjects' responses in questionnaires that measure the severity of overactive bladder (OAB) symptoms and incontinence severity (Overactive Bladder Questionnaire-Short Form, Incontinence Severity Index and the Patient Perception of Bladder Condition), the impact of those symptoms on quality of life (Pelvic Organ Prolapse Incontinence Sexual Questionnaire-12), change in pad counts and urinary frequency, differences in subjects' attainment of expectations for treatment following therapy. Baseline occurrence of irritable bowel and painful bladder syndrome will be recorded and their potential change in severity following treatment will be explored.
- a. The Hypothesis: Among patients with urgency urinary incontinence, hypnotherapy decreases abnormal perception of bladder distension outside the hypnotic state and is at least as effective as pharmacotherapy in diminishing the symptoms of urgency and severity of incontinence
A comparison of pre-treatment brain function in a subgroup of subjects with UUI to normal controls and an evaluation of post-treatment effect of hypnotherapy and pharmacotherapy on brain function in UUI subjects.
- Approximately sixty women with UUI will undergo functional magnetic resonance imaging (fMRI) before treatment and these baseline results will be compared to approximately 20-30 normal controls.
- The same 60 UUI subjects will also undergo fMRI analysis after receiving hypnotherapy or pharmacotherapy for two months. Post treatment fMRI results from UUI subjects will be compared to their baseline results.
Measured outcomes will be differences in baseline brain function in UUI subjects compared to normal controls as well as differences in treatment effect on brain function in subjects receiving pharmacotherapy compared to those receiving hypnotherapy
2a.The Hypotheses: 1) Patients with UUI will exhibit increased activation within portions of the brain, the limbic cortex (anterior cingulate cortex& insula), during bladder distension relative to controls. Patients will also exhibit an abnormal pattern of functional connectivity within these parts of the brain. 2) Among patients with UUI, hypnotherapy will decrease hyper-activation of portions of the brain in response to bladder distension and/or modulate functional connectivity within these portions of the brain. Moreover, normalization of hyper-activation and connectivity will be greater in hypnotherapy compared to pharmacotherapy.
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|
- Urgency Urinary Incontinence episodes recorded on voiding diaries [ Time Frame: Baseline and 2, 6 and 12 months post treatment ] [ Designated as safety issue: No ]Between group comparisons of Post-treatment change in urinary incontinence episodes recorded on voiding diaries
- Evoked brain activation and resting connectivity on functional MRI [ Time Frame: Baseline and 2 month post-treatment ] [ Designated as safety issue: No ]Post treatment change relative to pretreatment in UUI subjects who have undergone pharmacotherapy vs hypnotherapy treatments, evaluating evoked brain activation in the limbic cortex in response to urinary bladder distension and change in limbic system resting connectivity as measured with functional MRI
- Urinary urge incontinence cure [ Time Frame: 2, 6 & 12 months post treatment ] [ Designated as safety issue: No ]UUI "cure" , defined as complete resolution of UUI on any voiding diary performed 2,6 and 12 months following enrollment or "durable cure" defined as complete resolution of UUI on all post-treatment voiding diaries.
- 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.
|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, MDemail@example.com|
|Contact: Loren Ketai, MDfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Loren Ketai, MD 505-272-2269 firstname.lastname@example.org|
|Principal Investigator: Yuko Komesu, MD|
|Principal Investigator:||Yuko Komesu, MD||University of New Mexcio Health Science Center|