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OpenTrials
Completed

NCT Number: NCT03722992

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

TriHealth - Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBSR

Other

Guided yoga and meditation practices

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2018
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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