Back to resultsThe Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients
Primary Purpose
Interstitial Cystitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBSR
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis
Eligibility 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
Sites / Locations
- TriHealth - Cincinnati Urogynecology Associates
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mindfulness Cohort
Arm Description
Mindfulness-based stress reduction (MBSR) treatment group
Outcomes
Primary Outcome Measures
Difference in the urinary microbiome before and after MBSR treatment
Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03722992
Brief Title
The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients
Official Title
The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Cohort
Arm Type
Other
Arm Description
Mindfulness-based stress reduction (MBSR) treatment group
Intervention Type
Other
Intervention Name(s)
MBSR
Intervention Description
Guided yoga and meditation practices
Primary Outcome Measure Information:
Title
Difference in the urinary microbiome before and after MBSR treatment
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Pauls, MD
Organizational Affiliation
TriHealth - Cincinnati Urogynecology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
TriHealth - Cincinnati Urogynecology Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients
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