Clinical trial NCT01843543: Examining Bladder Control Using Mindful Based Approach
Official title: Assessing the Therapeutic Effect of Mindfulness-based Stress Reduction Intervention in Women With Urgency Incontinence Using Advanced Brain Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Urgency Incontinence
Keywords: Functional MRI (fMRI)
Resting state functional connectivity MRI (rs-fcMRI)
Diffusion Tensor Imaging (DTI)
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 12
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Functional Magnetic Resonance Imaging (fMRI)
timeFrame: Administered before and within 6 weeks after participation in the MBSR course
Secondary outcomes:
measure: Change in Overactive Bladder Symptom and Quality of Life Short Form
timeFrame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
measure: Change in Patient Global Impression of Severity and Improvement
timeFrame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
measure: Change in Beck Anxiety Inventory
timeFrame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
measure: Change in Mindfulness Attention Awareness Scale
timeFrame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
measure: Change in Perceived Stress Scale
timeFrame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
measure: Change in Urogenital Distress Inventory - Short Form
timeFrame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
measure: Change in Urinary Incontinence Episodes in 3-Day Period
timeFrame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
measure: Change in Resting State Functional Connectivity Magnetic Resonance Imaging (rs-fcMRI)
timeFrame: Administered before and within 6 weeks after participation in the MBSR course
measure: Change in Diffusion Tensor Imaging (DTI)
timeFrame: Administered before and within 6 weeks after participation in the MBSR course
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
Study officials:
References: