Examining Bladder Control Using Mindful Based Approach

Study Overview
=================
Brief Summary
-----------------
Urgency Incontinence (where the bladder muscles contract suddenly, causing an immediate urge to urinate that is difficult to prevent) is commonly experienced in patients with overactive bladder. New findings have discovered that urgency incontinence may be connected to the interactions of certain regions of the brain and the bladder. Although this is a common problem, researched still do not know how these interactions impact the process of urgency incontinence. Furthermore, there is preliminary data to suggest that interventions such as Mindful-Based Stress Reduction (MBSR) can potentially be used as therapy for UI. The purpose of this study is to determine the impact MBSR training on UI symptoms, quality of life, and anxiety measures.

Detailed Description
-----------------
Urgency Incontinence (where the bladder muscles contract suddenly, causing an immediate urge to urinate that is difficult to prevent) is commonly experienced in patients with overactive bladder. New findings have discovered that urgency incontinence may be connected to the interactions of certain regions of the brain and the bladder. Although this is a common problem, researched still do not know how these interactions impact the process of urgency incontinence. Furthermore, there is preliminary data to suggest that interventions such as Mindful-Based Stress Reduction (MBSR) can potentially be used as therapy for UI. The purpose of this study is to determine the impact MBSR training on UI symptoms, quality of life, and anxiety measures. To determine the impact of MBSR training on Urinary Incontinence(UI) symptoms, quality of life and anxiety measures in women affected with UI. We hypothesize that participants will have significant improvement in UI and anxiety related symptoms and quality of life measures.

Official Title
-----------------
Assessing the Therapeutic Effect of Mindfulness-based Stress Reduction Intervention in Women With Urgency Incontinence Using Advanced Brain Imaging

Conditions
-----------------
Urinary Urgency Incontinence

Intervention / Treatment
-----------------
* Other: Mindfulness Based Stress Reduction Course


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female participants with urinary urgency incontinence 40-85 years of age without a history of incontinence surgery current overactive bladder symptoms including urgency and urgency incontinence daily for the previous three months willing and able to complete all study related measures Exclusion Criteria: medical contraindications for MRI scanning past or present overt neurological disease history of pelvic irradiation or bladder cancer current urinary tract infection current pelvic pain or painful bladder disorder symptomatic pelvic organ prolapse anticholinergic medication use within 2 weeks of baseline assessments past nonpharmacologic treatment for UI history of structured mindfulness based course or therapy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR participants<br>Subjects in this arm will participate in an 8 week Mindfulness Based Stress Reduction Course | Other: Mindfulness Based Stress Reduction Course<br>* The MBSR course developed by Jon Kabat-Zinn is a mind-body intervention that incorporates mindfulness techniques. This is an eight week MBSR course at OHSU. Class instruction will be augmented by daily home practices of listening to audiotapes, diary reflections, and reading preloaded on itouch devices provided to participants. Adherence will be assessed through in-house iMINDr tracking program loaded on the itouch.<br>|
| No Intervention: No MBSR Participants<br>Subjects in this arm will not participate in the Mindfulness Based Stress Reduction Course. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Magnetic Resonance Imaging (fMRI) | To use advanced brain imaging techniques, namely functional MRI (fMRI) to determine whether change in Urinary Incontinence and anxiety symptoms after a Mindfulness Based Stress Reduction course are associated with changes in activation patterns in the brain. | Administered before and within 6 weeks after participation in the MBSR course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overactive Bladder Symptom and Quality of Life Short Form | A questionnaire validated for overactive bladder patients that includes symptom bother and health-related quality-of-life questions | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | 
| Change in Patient Global Impression of Severity and Improvement | single-question global indexes for Urinary Incontinence severity and improvement | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | 
| Change in Beck Anxiety Inventory | A self-report questionnaire for anxiety consisting of 21 items with items describing physical, physiological and cognitive aspects of anxiety | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | 
| Change in Mindfulness Attention Awareness Scale | A 15 item trait measure of the tendency to attend to present moment experiences in everyday activities | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | 
| Change in Perceived Stress Scale | A 10 item self report questionnaire aimed to tap experiences of distress related to 'how unpredictable, uncontrollable, and overloaded respondents find their lives | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | 
| Change in Urogenital Distress Inventory - Short Form | A 6 item self report questionnaire with items assessing life quality and symptom distress for urinary incontinence | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | 
| Change in Urinary Incontinence Episodes in 3-Day Period | Subjects will be asked to keep a diary that tracks their bladder and urinary habits for 3 days | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | 
| Change in Resting State Functional Connectivity Magnetic Resonance Imaging (rs-fcMRI) | To use advanced brain imaging techniques, namely functional connectivity MRI to determine whether change in Urinary Incontinence and anxiety symptoms after a Mindfulness Based Stress Reduction course are associated with changes functional connectivity patterns in the brain. | Administered before and within 6 weeks after participation in the MBSR course | 
| Change in Diffusion Tensor Imaging (DTI) | To use advanced brain imaging techniques, namely diffusion tensor Imaging(DTI) to assess white matter integrity and fiber tracking. | Administered before and within 6 weeks after participation in the MBSR course | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional MRI (fMRI), Resting state functional connectivity MRI (rs-fcMRI), Diffusion Tensor Imaging (DTI)