Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-24 @ 12:26 AM
Study NCT ID:
NCT03722992
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2018-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the urinary microbiome before and after MBSR treatment', 'timeFrame': 'Before intervention and after completion of the intervention, up to 9 weeks', 'description': 'Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Cystitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nMindfulness-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.\n\nThe purpose of this study is to compare measurable differences in the urinary microbiome among women with IC before and after MBSR treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults 18 years of age or older\n* English-speaking\n* Established patient of Cincinnati Urogynecology Associates, TriHealth Inc.\n* Current diagnosis of IC/PBS, as defined by the American Urological Association (AUA)\n* Negative urinalysis or urine culture within 2 months of enrollment\n* Currently undergoing first or second-line treatment for IC, as defined by the AUA\n* Willingness to participate in study\n\nExclusion Criteria:\n\n* Non-English speaking\n* Unwillingness to participate in study\n* Pregnancy or breastfeeding\n* 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\n* Current or expected prolonged catheterization\n* Expected travel or surgery that would hinder the ability to attend all eight MBSR sessions\n* Undergoing third-, fourth-, fifth-, or sixth-line treatment for IC as defined by the AUA\n* Subjects on antibiotics currently or prior use within one week of consenting"}, 'identificationModule': {'nctId': 'NCT03722992', 'briefTitle': 'The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome', 'orgStudyIdInfo': {'id': '18-056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mindfulness Cohort', 'description': 'Mindfulness-based stress reduction (MBSR) treatment group', 'interventionNames': ['Other: MBSR']}], 'interventions': [{'name': 'MBSR', 'type': 'OTHER', 'description': 'Guided yoga and meditation practices', 'armGroupLabels': ['Mindfulness Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'TriHealth - Cincinnati Urogynecology Associates', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Rachel Pauls, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriHealth - Cincinnati Urogynecology Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}