Interstitial Cystitis Clinical Trial
Official title:
The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome
NCT number | NCT03722992 |
Other study ID # | 18-056 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 7, 2019 |
Est. completion date | March 15, 2020 |
Verified date | November 2019 |
Source | TriHealth Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | March 15, 2020 |
Est. primary completion date | January 15, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | TriHealth - Cincinnati Urogynecology Associates | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
TriHealth Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in the urinary microbiome before and after MBSR treatment | Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory | Before intervention and after completion of the intervention, up to 9 weeks |
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