Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05117918
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2021-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Overactive Bladder Telemedicine Non-inferiority Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], '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'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': '1 year', 'description': 'Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction'}], 'secondaryOutcomes': [{'measure': 'PGII', 'timeFrame': '1 year', 'description': 'Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved'}, {'measure': 'Incidence of Treatment-emergent adverse events (safety and tolerability)', 'timeFrame': '1 year', 'description': 'Adverse events related to treatment requiring emergency room visits, urgent care visits, hospital admissions'}, {'measure': 'Accumulated cost of visit to patient (Cost)', 'timeFrame': '1 year', 'description': 'Cost of parking, travel, and other visit-associated expenses to patient'}, {'measure': 'Accumulated time of visit for patient (Time)', 'timeFrame': '1 year', 'description': 'Time of travel to visit, time of visit, wait time of visit'}, {'measure': 'Overactive Bladder Symptoms', 'timeFrame': '1 year', 'description': 'Overactive Bladder Questionnaire Short-Form (OAB-q SF), scale from 6-36 with 36 indicating the most severe OAB symptoms'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (OAB).', 'detailedDescription': 'This is a single-center, prospective randomized controlled trial. The study population will consist of two primary cohorts stratified based on the method of follow-up, either traditional in-person clinic visit or telemedicine appointment. The primary outcome will be satisfaction with OAB treatment. Secondary endpoints include rate of progression to third line therapies, changes in OAB symptom scores, safety, and cost. This non-inferiority trial is designed to provide an alternative option for care delivery that may result in improved patient satisfaction and compliance, and decreased cost, time, and travel burden for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic overactive bladder diagnosis, both OAB wet and OAB dry\n\nExclusion Criteria:\n\n* Active Urinary Tract Infection (UTI)\n* Stage 3 or 4 prolapse\n* Underlying neurologic condition contributing to OAB\n* Use of catheter'}, 'identificationModule': {'nctId': 'NCT05117918', 'acronym': 'OAB Telemed', 'briefTitle': 'Overactive Bladder Telemedicine Non-inferiority Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'A Prospective Study Evaluating the Feasibility of Telemedicine Use in the Overactive Bladder Clinical Care Pathway: a Non-inferiority Study Assessing Patient Satisfaction and Progression to Third Line Overactive Bladder Therapies', 'orgStudyIdInfo': {'id': '21-000458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Traditional In-Person Clinic Visit Arm', 'description': 'Patients will receive overactive bladder (OAB) treatment as described in the Society for Urodynamics and Female Pelvic Medicine and Urogenital Reconstruction (SUFU) OAB clinical care pathway. These patients will have all visits in-person', 'interventionNames': ['Other: SUFU Clinical Care Pathway for Overactive Bladder']}, {'type': 'EXPERIMENTAL', 'label': 'Telemedicine Arm', 'description': 'Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine', 'interventionNames': ['Other: SUFU Clinical Care Pathway for Overactive Bladder', 'Other: Telemedicine']}], 'interventions': [{'name': 'SUFU Clinical Care Pathway for Overactive Bladder', 'type': 'OTHER', 'description': 'Treatment of OAB via the SUFU clinical care pathway', 'armGroupLabels': ['Telemedicine Arm', 'Traditional In-Person Clinic Visit Arm']}, {'name': 'Telemedicine', 'type': 'OTHER', 'description': 'Delivery of care via telemedicine', 'armGroupLabels': ['Telemedicine Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology, Chief, Division of Female Pelvic Medicine and Reconstructive Surgery', 'investigatorFullName': 'Victor W. Nitti, MD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}