Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-06 @ 10:03 AM
Study NCT ID:
NCT00546858
Status:
COMPLETED
Last Update Posted:
2009-05-05
First Post:
2007-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship of Interstitial Cystitis to Vulvodynia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D056650', 'term': 'Vulvodynia'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-04', 'studyFirstSubmitDate': '2007-10-18', 'studyFirstSubmitQcDate': '2007-10-18', 'lastUpdatePostDateStruct': {'date': '2009-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The purpose of this two-part study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC).', 'timeFrame': 'Prospective'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pelvic pain', 'Vulvar pain'], 'conditions': ['Interstitial Cystitis']}, 'descriptionModule': {'briefSummary': "This study is important in urologic nursing since many patients have interstitial cystitis (IC), a condition of frequency, urgency and pain affecting more than 1 million women in the United States. The vulva may actually be the site of some of the reported pain in women with IC, not the urethra or bladder. IC and vulvodynia can impact one's sexual functioning and diminish one's quality of life.\n\nThe purpose of this two-part study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of Interstitial Cystitis from the practices of Dr Ananias Diokno and Dr Kenneth Peters will be mailed a survey.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females who are 18 years of age and older.\n* Diagnosis of interstitial cystitis'}, 'identificationModule': {'nctId': 'NCT00546858', 'briefTitle': 'Relationship of Interstitial Cystitis to Vulvodynia', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Part A: STUDY OF THE RELATIONSHIP OF INTERSTITIAL CYSTITIS TO VULVODYNIA', 'orgStudyIdInfo': {'id': '2007-183'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survey', 'description': 'Patients with interstitial cystitis', 'interventionNames': ['Other: Physical Examination']}], 'interventions': [{'name': 'Physical Examination', 'type': 'OTHER', 'description': 'Patients will be invited to be evaluated in the Urology Research office at a future date.', 'armGroupLabels': ['Survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Donna Carrico, NP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}}}}