Expired Study
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Cincinnati, Ohio 45220


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03722992


Primary Contact:

Principal Investigator
Rachel Pauls, MD
TriHealth - Cincinnati Urogynecology Associates


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45220
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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