Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05981794
Status:
WITHDRAWN
Last Update Posted:
2025-05-23
First Post:
2023-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heating Pad for in Office Cystoscopy and Urodynamic Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized in a 1:1 manner to the treatment group (those receiving a heating pad with heat during the procedure) or control group (those who receive a heating pad without heat). The study is prospective, and randomization will be performed by a random allocation table. Randomization will be stratified by sex, procedure, and provider.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI left institution and changed to new PI, there was no funding secured for this study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2023-07-22', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety visual analog scale (VAS)', 'timeFrame': 'Pre- and Post-procedure (about 30 minutes)', 'description': 'Change in score on a 10-point visual analog scale where where 0 indicates the least amount of anxiety and 10 the greatest'}, {'measure': 'Hospital Anxiety and Depression Survey (HADS)', 'timeFrame': 'Pre- and Post-procedure (about 30 minutes)', 'description': 'Change in score on the anxiety subscale score, a total score of 0-21 is possible, with a score between 0-7= Normal, 8-10= Borderline abnormal and 11-21= abnormal'}, {'measure': 'Change in Pain (VAS)', 'timeFrame': 'Pre- and Post-procedure (about 30 minutes)', 'description': 'Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of pain and 10 the greatest'}, {'measure': 'Change in Distress (VAS)', 'timeFrame': 'Pre- and Post-procedure (about 30 minutes)', 'description': 'Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of distress and 10 the greatest'}, {'measure': 'Blood pressure measure', 'timeFrame': 'Pre- and Post-procedure (about 30 minutes)', 'description': 'Change in blood pressure'}, {'measure': 'Heart rate', 'timeFrame': 'Pre- and Post-procedure (about 30 minutes)', 'description': 'Change in heart rate'}], 'secondaryOutcomes': [{'measure': 'Wait time', 'timeFrame': 'Pre-procedure to beginning of procedure (about 30 minutes)', 'description': 'Amount of time spent waiting prior to procedure'}, {'measure': 'Time spent on procedure', 'timeFrame': 'Pre- to Post-procedure (about 30 minutes)', 'description': 'Amount of time taken to complete procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cystoscopy', 'Urodynamic study'], 'conditions': ['Anxiety', 'Pain', 'Distress, Emotional']}, 'descriptionModule': {'briefSummary': 'Patient frequently report experiencing discomfort associated with cystoscopy or urodynamic studies (UDS), and a small percentage of patients refuse these important procedures due to discomfort or fear of discomfort. Heating pads are an inexpensive and low-risk way to reduce patient discomfort during these procedures, which to our knowledge has not been investigated in the United States.', 'detailedDescription': 'Invasive office procedures such as cystoscopy and urodynamic studies (UDS) are commonly performed for many urologic and Urogynecologic conditions including, but not limited to, incontinence, voiding dysfunction, urinary retention, hematuria, and other lower urinary tract symptoms. Cystoscopy involves the insertion of a rigid or flexible cystoscope through the urethra and into the bladder. Urodynamic studies involve the placement of urethral and rectal catheters. Both cystoscopy and UDS involve filling the bladder with fluid, and these procedures are essential to the diagnosis and management of many of the conditions listed above.\n\nWhile both procedures are office procedures that are generally well tolerated, some patients can experience significant discomfort, pain, or anxiety. Some nonpharmacologic therapies have been investigated to relieve anxiety, pain, and distress, such as music and aromatherapy. Heating treatments are also known to reduce muscle pain by increasing local blood flow and decreasing distress. The use of a heating pad has become an established complementary modality in some invasive procedures. A previous study from South Korea has shown benefit of heating pad use for anxiety, pain, and distress during cystoscopy and UDS; however to our knowledge, there are no studies evaluating the effect of heating pad use on patients in the United States, who may have inherent demographical differences compared to patients from South Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Able to give informed consent\n* Able to read and write English or Spanish\n\nExclusion Criteria:\n\n* Refusal to participate\n* Contraindications to cystoscopy or urodynamic testing\n* Patients who receive other procedures or treatment at the time of cystoscopy, such as bladder biopsy or Botox injection\n* Patients with spinal cord injury or lack of sensation'}, 'identificationModule': {'nctId': 'NCT05981794', 'briefTitle': 'Heating Pad for in Office Cystoscopy and Urodynamic Testing', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HSC20230455H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heating Pad heated', 'description': 'An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure', 'interventionNames': ['Device: Electrical heating pad']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo heating pad', 'description': 'An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure', 'interventionNames': ['Device: Sham heating pad']}], 'interventions': [{'name': 'Electrical heating pad', 'type': 'DEVICE', 'otherNames': ['Heating pad'], 'description': 'A powered heating pad', 'armGroupLabels': ['Heating Pad heated']}, {'name': 'Sham heating pad', 'type': 'DEVICE', 'otherNames': ['Non-heated heating pad'], 'description': 'A heating pad that is not powered on', 'armGroupLabels': ['Placebo heating pad']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Jasmine Tibon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health Science Center San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'When summary data are published or otherwise made available at study completion', 'ipdSharing': 'YES', 'description': 'All de-identified IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}