The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients

TriHealth Inc.14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interstitial Cystitis

Interventions

MBSROTHER

Guided yoga and meditation practices

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

TriHealth - Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Difference in the urinary microbiome before and after MBSR treatment

Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory

Time frame: Before intervention and after completion of the intervention, up to 9 weeks

Data from ClinicalTrials.gov

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