- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03722992
The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients
The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- TriHealth - Cincinnati Urogynecology Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Mindfulness Cohort
Mindfulness-based stress reduction (MBSR) treatment group
|
Guided yoga and meditation practices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the urinary microbiome before and after MBSR treatment
Time Frame: Before intervention and after completion of the intervention, up to 9 weeks
|
Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory
|
Before intervention and after completion of the intervention, up to 9 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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