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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03722992
Recruitment Status : Completed
First Posted : October 29, 2018
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Other: MBSR Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Actual Study Start Date : March 7, 2019
Actual Primary Completion Date : January 15, 2020
Actual Study Completion Date : March 15, 2020

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Arms and Interventions
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Arm Intervention/treatment
Mindfulness Cohort
Mindfulness-based stress reduction (MBSR) treatment group
 Other: MBSR
Guided yoga and meditation practices


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722992


Locations
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United States, Ohio
TriHealth - Cincinnati Urogynecology Associates
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Rachel Pauls, MD TriHealth - Cincinnati Urogynecology Associates
More Information
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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT03722992    
Other Study ID Numbers: 18-056
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases