Assessing the Therapeutic Effect of Mindfulness-based Stress Reduction Intervention in Women With Urgency Incontinence Using Advanced Brain Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Functional Magnetic Resonance Imaging (fMRI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Functional Magnetic Resonance Imaging (fMRI)
时间窗: 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.
次要结局
- 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)
研究者
Rahel Nardos
Assistant Professor
Oregon Health and Science University