Examining Bladder Control Using Mindful Based Approach

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Urgency Incontinence
• Intervention / Treatment: Other: Mindfulness Based Stress Reduction Course

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBSR participants; Subjects in this arm will participate in an 8 week Mindfulness Based Stress Reduction Course	Other: Mindfulness 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.
No Intervention: No MBSR Participants; 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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 26, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): April 30, 2013

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Diffusion Tensor Imaging (DTI); Functional MRI (fMRI); Resting state functional connectivity MRI (rs-fcMRI)
• Other Study ID Numbers: OHSU_9405