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Clinical Trials/NCT01843543
NCT01843543
Completed
Not Applicable

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

Oregon Health and Science University1 site in 1 country12 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Urgency Incontinence
Sponsor
Oregon Health and Science University
Enrollment
12
Locations
1
Primary Endpoint
Change in Functional Magnetic Resonance Imaging (fMRI)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
May 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rahel Nardos

Assistant Professor

Oregon Health and Science University

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

Outcomes

Primary Outcomes

Change in Functional Magnetic Resonance Imaging (fMRI)

Time Frame: 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 Outcomes

  • 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 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)
  • Change in Perceived Stress Scale(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 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 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 Urogenital Distress Inventory - Short Form(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)(Administered before and within 6 weeks after participation in the MBSR course)
  • Change in Diffusion Tensor Imaging (DTI)(Administered before and within 6 weeks after participation in the MBSR course)

Study Sites (1)

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