Urinary Urgency IncontinenceNCT01843543
Examining Bladder Control Using Mindful Based Approach
A study testing Mindfulness Based Stress Reduction Course in people with Urinary Urgency Incontinence, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women only
- Conditions the study is for
- Urinary Urgency Incontinence
- What is being tested?
- Mindfulness Based Stress Reduction Course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- anticholinergic medication use within 2 weeks of baseline assessments
- past nonpharmacologic treatment for UI
- history of structured mindfulness based course or therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Urgency Incontinence
- Being tested
- Mindfulness Based Stress Reduction Course
- Keywords
- Functional MRI (fMRI), Resting state functional connectivity MRI (rs-fcMRI), Diffusion Tensor Imaging (DTI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction CourseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MBSR participants | Experimental | Subjects in this arm will participate in an 8 week Mindfulness Based Stress Reduction Course Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A questionnaire validated for overactive bladder patients that includes symptom bother and health-related quality-of-life questions
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Administered before and within 6 weeks after participation in the MBSR course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Urgency IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahel Nardos, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843543
- Sponsor's protocol ID
- OHSU_9405
- Status last verified
- Dec 2019
- First submitted
- 26 Apr 2013
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Therapeutic Effect of Mindfulness-based Stress Reduction Intervention in Women With Urgency Incontinence Using Advanced Brain Imaging
- ClinicalTrials.gov ID
- NCT01843543
- Acronym / sponsor ID
- OHSU_9405
- Conditions
- Urinary Urgency Incontinence
- Keywords
- Functional MRI (fMRI), Resting state functional connectivity MRI (rs-fcMRI), Diffusion Tensor Imaging (DTI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR participants | Experimental | Other: Mindfulness Based Stress Reduction CourseSubjects in this arm will participate in an 8 week Mindfulness Based Stress Reduction Course |
| No MBSR Participants | No intervention | –Subjects in this arm will not participate in the Mindfulness Based Stress Reduction Course. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress Reduction CourseThe 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. | Other | MBSR participants |
Primary outcome
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
Change in Diffusion Tensor Imaging (DTI)
Time frame: Administered before and within 6 weeks after participation in the MBSR course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction Course in people with Urinary Urgency Incontinence, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Magnetic Resonance Imaging (fMRI) (time frame: Administered before and within 6 weeks after participation in the MBSR course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.