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Examining Bladder Control Using Mindful Based Approach

NCT ID: NCT01843543

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Urinary Urgency Incontinence

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBSR participants

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

Group Type EXPERIMENTAL

Mindfulness Based Stress Reduction Course

Intervention Type 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.

No MBSR Participants

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Rahel Nardos

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oregon Health Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OHSU_9405

Identifier Type: -

Identifier Source: org_study_id