Urinary Urgency Incontinence
Conditions
Keywords
Functional MRI (fMRI), Resting state functional connectivity MRI (rs-fcMRI), Diffusion Tensor Imaging (DTI)
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.
Interventions
OTHERMindfulness Based Stress Reduction Course
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.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Magnetic Resonance Imaging (fMRI) | Administered before and within 6 weeks after participation in the MBSR course | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Global Impression of Severity and Improvement | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | single-question global indexes for Urinary Incontinence severity and improvement |
| Change in Beck Anxiety Inventory | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | A self-report questionnaire for anxiety consisting of 21 items with items describing physical, physiological and cognitive aspects of anxiety |
| Change in Mindfulness Attention Awareness Scale | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | A 15 item trait measure of the tendency to attend to present moment experiences in everyday activities |
| Change in Perceived Stress Scale | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | A 10 item self report questionnaire aimed to tap experiences of distress related to 'how unpredictable, uncontrollable, and overloaded respondents find their lives |
| Change in Overactive Bladder Symptom and Quality of Life Short Form | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | A questionnaire validated for overactive bladder patients that includes symptom bother and health-related quality-of-life questions |
| Change in Urinary Incontinence Episodes in 3-Day Period | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | Subjects will be asked to keep a diary that tracks their bladder and urinary habits for 3 days |
| Change in Resting State Functional Connectivity Magnetic Resonance Imaging (rs-fcMRI) | Administered before and within 6 weeks after participation in the MBSR course | 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. |
| Change in Diffusion Tensor Imaging (DTI) | Administered before and within 6 weeks after participation in the MBSR course | To use advanced brain imaging techniques, namely diffusion tensor Imaging(DTI) to assess white matter integrity and fiber tracking. |
| Change in Urogenital Distress Inventory - Short Form | Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention | A 6 item self report questionnaire with items assessing life quality and symptom distress for urinary incontinence |
Countries
United States
Outcome results
None listed