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

NCT03722992 | Completed

• 1 other identifier: 18-056
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Mindfulness Cohort

OTHER

Mindfulness-based stress reduction (MBSR) treatment group

Other: MBSR

Interventions

MBSR OTHER

Guided yoga and meditation practices

Mindfulness Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth - Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 29, 2018
• Study Start: March 7, 2019
• Primary Completion: January 15, 2020
• Study Completion: March 15, 2020
• Last Updated: July 23, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)