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

NCT ID: NCT03722992

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-07
• Study Completion Date: 2020-03-15

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.

Conditions

Interstitial Cystitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness Cohort

Mindfulness-based stress reduction (MBSR) treatment group

Group Type: OTHER

MBSR

Intervention Type: OTHER

Guided yoga and meditation practices

Interventions

MBSR

Guided yoga and meditation practices

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Pauls, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth - Cincinnati Urogynecology Associates

Locations

TriHealth - Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

18-056

Identifier Type: -

Identifier Source: org_study_id