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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03722992
Other study ID # 18-056
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2019
Est. completion date March 15, 2020

Study information

Verified date November 2019
Source TriHealth Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date March 15, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MBSR
Guided yoga and meditation practices

Locations

Country Name City State
United States TriHealth - Cincinnati Urogynecology Associates Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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