The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Difference in the urinary microbiome before and after MBSR treatment
研究概览
简要总结
This is a prospective cohort study to investigate differences in the bladder environment (i.e. urinary microbiome) amongst women with interstitial cystitis (IC) before and after undergoing mindfulness-based stress reduction (MBSR) treatment, including yoga and meditation practices.
详细描述
Interstitial cystitis (IC), or Painful Bladder Syndrome (PBS) is a debilitating condition of the bladder that is estimated to affect 3-8 million women in the United States. The pathophysiology of the disease is poorly understood, and thus treatment modalities and treatment efficacy vary widely. Lately, much attention has shifted toward investigating how the bladder 'environment' differs amongst women with IC compared to those who do not suffer from IC.
Mindfulness-based stress reduction (MBSR), a complementary alternative medicine (CAM)-based therapy, is a standardized program including components of meditation and yoga. Recent studies show that MBSR improves symptoms in the IC patient population.
The purpose of this study is to compare measurable differences in the urinary microbiome among women with IC before and after MBSR treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age or older
- •English-speaking
- •Established patient of Cincinnati Urogynecology Associates, TriHealth Inc.
- •Current diagnosis of IC/PBS, as defined by the American Urological Association (AUA)
- •Negative urinalysis or urine culture within 2 months of enrollment
- •Currently undergoing first or second-line treatment for IC, as defined by the AUA
- •Willingness to participate in study
排除标准
- •Non-English speaking
- •Unwillingness to participate in study
- •Pregnancy or breastfeeding
- •Physical or mental impairment that would affect the subject's ability to participate in the MBSR treatment, including patients with Dementia, Parkinsonism, or those who have impaired mobility or hearing
- •Current or expected prolonged catheterization
- •Expected travel or surgery that would hinder the ability to attend all eight MBSR sessions
- •Undergoing third-, fourth-, fifth-, or sixth-line treatment for IC as defined by the AUA
- •Subjects on antibiotics currently or prior use within one week of consenting
结局指标
主要结局
Difference in the urinary microbiome before and after MBSR treatment
时间窗: Before intervention and after completion of the intervention, up to 9 weeks
Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory
次要结局
未报告次要终点