The Effects of Mindfulness-based Stress Reduction in Inte... | NCT03722992

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

NCT03722992

Sponsor

TriHealth Inc.

Status

Completed

Last Update Posted

Jul 23, 2020Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Interstitial Cystitis

Interventions

MBSR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2019Actual

Primary Completion Date

Jan 15, 2020Actual

Completion Date

Mar 15, 2020Actual

First Submitted Date

Oct 24, 2018

First Submission Date that Met QC Criteria

Oct 25, 2018

First Posted Date

Oct 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2020

Last Update Posted Date

Jul 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness Cohort	Other	Mindfulness-based stress reduction (MBSR) treatment group	Other: MBSR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MBSR	Other	Guided yoga and meditation practices	Mindfulness Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel Pauls, MD	TriHealth - Cincinnati Urogynecology Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TriHealth - Cincinnati Urogynecology Associates		Cincinnati	Ohio	45220	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial

Ancestor Terms

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

Not provided