Examining Bladder Control Using Mindful Based Approach

NCT01843543 | Completed

• 1 other identifier: OHSU_9405
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Urgency Incontinence

Keywords

Functional MRI (fMRI); Resting state functional connectivity MRI (rs-fcMRI); Diffusion Tensor Imaging (DTI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

• Change in Beck Anxiety Inventory

  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

  Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention

• Change in Perceived Stress Scale

  Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention

Study Arms (2)

MBSR participants

EXPERIMENTAL

Subjects in this arm will participate in an 8 week Mindfulness Based Stress Reduction Course

Other: Mindfulness Based Stress Reduction Course

No MBSR Participants

NO INTERVENTION

Subjects in this arm will not participate in the Mindfulness Based Stress Reduction Course.

Interventions

Mindfulness Based Stress Reduction Course OTHER

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.

MBSR participants

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants with urinary urgency incontinence
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: April 30, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

US (1)