Interstitial Cystitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERMBSR
Guided yoga and meditation practices
Sponsors
TriHealth Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the urinary microbiome before and after MBSR treatment | Before intervention and after completion of the intervention, up to 9 weeks | Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory |
Countries
United States
Outcome results
None listed