Skip to main content
OpenTrials
Completed

NCT Number: NCT01843543

Examining Bladder Control Using Mindful Based Approach

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Urgency Incontinence

Age range

40 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Change in Overactive Bladder Symptom and Quality of Life Short Form

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

    A questionnaire validated for overactive bladder patients that includes symptom bother and health-related quality-of-life questions

  2. Change in Patient Global Impression of Severity and Improvement

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

    single-question global indexes for Urinary Incontinence severity and improvement

  3. Change in Beck Anxiety Inventory

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

    A self-report questionnaire for anxiety consisting of 21 items with items describing physical, physiological and cognitive aspects of anxiety

  4. Change in Mindfulness Attention Awareness Scale

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

    A 15 item trait measure of the tendency to attend to present moment experiences in everyday activities

  5. Change in Perceived Stress Scale

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

    A 10 item self report questionnaire aimed to tap experiences of distress related to 'how unpredictable, uncontrollable, and overloaded respondents find their lives

  6. Change in Urogenital Distress Inventory - Short Form

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

    A 6 item self report questionnaire with items assessing life quality and symptom distress for urinary incontinence

  7. Change in Urinary Incontinence Episodes in 3-Day Period

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

    Subjects will be asked to keep a diary that tracks their bladder and urinary habits for 3 days

  8. Change in Resting State Functional Connectivity Magnetic Resonance Imaging (rs-fcMRI)

    Time frame: Administered before and within 6 weeks after participation in the MBSR course

    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.

  9. Change in Diffusion Tensor Imaging (DTI)

    Time frame: Administered before and within 6 weeks after participation in the MBSR course

    To use advanced brain imaging techniques, namely diffusion tensor Imaging(DTI) to assess white matter integrity and fiber tracking.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 30, 2013
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.