Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-29 @ 9:40 PM
Study NCT ID:
NCT00903435
Status:
COMPLETED
Last Update Posted:
2011-12-01
First Post:
2009-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Studies of Urinary Bladder Sensation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}, {'id': 'D003556', 'term': 'Cystitis'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-30', 'studyFirstSubmitDate': '2009-04-23', 'studyFirstSubmitQcDate': '2009-05-15', 'lastUpdatePostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on the muscles or by applying a blood pressure cuff.', 'timeFrame': 'One and a half to two hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cystitis', 'Urinary', 'Bladder'], 'conditions': ['Interstitial Cystitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems.', 'detailedDescription': 'To determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems. Previous studies by the PI suggest that two populations of subjects are present in the IC population but a larger number of subjects with IC would need to be tested in order to determine if this were indeed true. Other studies have demonstrated that counterirritation-related effects are absent in several chronic pain populations including fibromyalgia and chronic headaches. Identification of a subset of IC patients or the identification of a failure of counterirritation-related effects may predict responses to therapeutic interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-healthy subjects will be recruited from Kirklin Clinic Urology Clinic and Pain Treatment Center. Healthy subjects will be recruited via advertisements.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to read and speak English\n* 19 years or older\n* IC Diagnosis\n\nExclusion Criteria:\n\n* Over 65 years old\n* Pregnant\n* Children younger than 19\n* Significant cardiac disease'}, 'identificationModule': {'nctId': 'NCT00903435', 'briefTitle': 'Quantitative Studies of Urinary Bladder Sensation', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Quantitative Studies of Urinary Bladder Sensation', 'orgStudyIdInfo': {'id': 'F060505003'}, 'secondaryIdInfos': [{'id': '3R01DK051413-11S1', 'link': 'https://reporter.nih.gov/quickSearch/3R01DK051413-11S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Quantitative Sensory Testing and Stimulus', 'type': 'OTHER', 'description': 'No therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Kirklin Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Timothy Ness, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Timothy Ness, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Timothy Ness, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}