Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-03 @ 8:02 PM
Study NCT ID:
NCT06577493
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Phenazopyridine for Pain Following Urodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010621', 'term': 'Phenazopyridine'}], 'ancestors': [{'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-22', 'size': 203174, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-19T11:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into experimental or control groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in pain scores, as measured by visual analog scale between study groups at 4 to 6 hours after urodynamic testing', 'timeFrame': '4 to 6 hours after testing', 'description': 'Scores are measured on a 100mm VAS. The VAS ranges from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain.'}], 'secondaryOutcomes': [{'measure': 'Difference in anxiety scores, as measured by visual analog scale between study groups at predetermined time points.', 'timeFrame': 'baseline (immediately prior to testing), immediately after testing, 4 to 6 hours after testing', 'description': 'Scores are measured on a 100mm VAS. The VAS ranges from 0 to 100 with 0 indicating no anxiety and higher scores indicating greater anxiety.'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - UDS procedure length time', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (UDS procedure length time) recorded in minutes'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - first sensation', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (first sensation) measured in mL'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - first desire', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (first desire) measured in mL'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - strong desire', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (strong desire) measured in mL'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - capacity', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (capacity) measured in mL'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - valsalva leak point pressure', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (valsalva leak point pressure) recorded in cmH20'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - max flow rate', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (max flow rate) is measured in mL/second'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - voided volume', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (voided volume) is measured in mL'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - void time', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (void time) is measured in minutes:seconds'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - flow time', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (flow time) is measured in minutes:seconds'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - average flow rate', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (average flow rate) is measured in mL/seconds'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - time to max flow', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (time to max flow) is measured in minutes:seconds'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - max detrusor pressure', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (max detrusor pressure) is measured in cm H20'}, {'measure': 'Difference in Urodynamic voiding parameters between experimental group and known normal values - post void residual volume', 'timeFrame': 'at time of testing', 'description': 'Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (post void residual volume) is measured in mL'}, {'measure': 'Number of patient communications', 'timeFrame': 'Per single participant (24 hours after completion of UDS testing)', 'description': 'Count the number of patient communications after the completion of study'}, {'measure': 'Would patients repeat urodynamic testing', 'timeFrame': '4 to 6 hours after testing', 'description': "Evaluate patients' willingness to undergo urodynamic testing again measured by a 1 to 5 likert scale with 1 being not at all likely and 5 being very likely"}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain After Urodynamic Testing']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if taking phenazopyridine (AZO) at the time of urodynamic study testing will decrease pain experienced by patients after undergoing urodynamic testing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability to provide informed consent\n* ability to complete visual analog scale\n* requiring urodynamic testing\n* 18 years of age or older\n* must be able to read and write in English or Spanish\n\nExclusion Criteria:\n\n* allergy to phenazopyridine\n* a urinary tract infection in the prior 2 weeks\n* women who did not undergo urodynamic testing\n* patient less than 18 years old\n* patients with known (noted in patient chart and verbally asked) severe renal insufficiency with GFR \\<50 mL/min,\n* patients with known (noted in patient chart and verbally asked) severe hepatitis\n* patients with known (noted in patient chart and verbally asked) G6PD deficiency\n* history of fibromyalgia\n* history of interstitial cystitis\n* non English or Spanish speaking'}, 'identificationModule': {'nctId': 'NCT06577493', 'briefTitle': 'Effectiveness of Phenazopyridine for Pain Following Urodynamics', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Effectiveness of Phenazopyridine for Pain Following Urodynamics', 'orgStudyIdInfo': {'id': '007227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'Patient to take two 99.5mg phenazopyridine hydrochloride (AZO) for a total of 199 mg by mouth once immediately prior to the start of urodynamic testing.', 'interventionNames': ['Drug: Phenazopyridine Hydrochloride 99.5 MG']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Patient to not receive any medication prior to the start of urodynamic testing.'}], 'interventions': [{'name': 'Phenazopyridine Hydrochloride 99.5 MG', 'type': 'DRUG', 'otherNames': ['AZO'], 'description': 'Experimental arm to take two 99.5 mg phenazopyridine hydrochloride by mouth for a total of 199mg immediately prior to start of urodynamic testing', 'armGroupLabels': ['Experimental Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Wilkinson, MD', 'role': 'CONTACT'}], 'facility': 'University of South Florida South Tampa Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Elizabeth Wilkinson, MD', 'role': 'CONTACT', 'email': 'wilkinsone@usf.edu', 'phone': '8139745638'}], 'overallOfficials': [{'name': 'Elizabeth A Wilkinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}