Overview

This trial is active, not recruiting.

Condition urinary urgency incontinence
Treatment mindfulness based stress reduction course
Sponsor Oregon Health and Science University
Start date April 2013
End date May 2015
Trial size 15 participants
Trial identifier NCT01843543, OHSU_9405

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects in this arm will participate in an 8 week Mindfulness Based Stress Reduction Course
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.
(No Intervention)
Subjects in this arm will not participate in the Mindfulness Based Stress Reduction Course.

Primary Outcomes

Measure
Mindfulness Based Stress Reduction
time frame: 8 week course occurring between the first and second MRI visits

Secondary Outcomes

Measure
Functional Magnetic Resonance Imaging (fMRI)
time frame: Administered before and within 6 weeks after participation in the MBSR course
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
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
Beck Anxiety Inventory
time frame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
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
Perceived Stress Scale
time frame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
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
Bladder Diary
time frame: Administered before and within 6 weeks after participation in the MBSR course. Repeated between 6-8 months post intervention
Resting State Functional Connectivity Magnetic Resonance Imaging (rs-fcMRI)
time frame: Administered before and within 6 weeks after participation in the MBSR course
Diffusion Tensor Imaging (DTI)
time frame: Administered before and within 6 weeks after participation in the MBSR course

Eligibility Criteria

Female participants from 40 years up to 85 years old.

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

Additional Information

Official title Assessing the Therapeutic Effect of Mindfulness-based Stress Reduction Intervention in Women With Urgency Incontinence Using Advanced Brain Imaging
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.