Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 7:40 PM
Study NCT ID:
NCT07475468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CP382 - Intermittent Catheter (IC) PRO Panel Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2032-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of IC products used by subjects.', 'timeFrame': '5 years', 'description': 'Characterization of a cohort of IC users at point-of-entry to the registry including but not limited to, IC product consumption, user-patterns, prescriptions, and use of supporting products.'}, {'measure': 'The number of urinary tract infections', 'timeFrame': '5 years', 'description': 'Frequency and consequences of urinary tract infections.'}, {'measure': 'The Mental well-being index (WHO-5)', 'timeFrame': '5 years', 'description': 'Quality-of-life (QoL) using the Mental well-being index (WHO-5). The subject has 5 questions asked, with 6 different responses available: "All of the time", "Most of the time", "More than half the time", "less than half the time", "some of the time", and "at no time". The choice of "all of the time" equates to a better well-being than a response of "at no time".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intermittent Catheterization']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '4) FDA, Center for Devices and Radiological Health: Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions (subsection IB, pages 50-55), March 2021, Link: https://www.fda.gov/media/146258/download)'}, {'pmid': '27053002', 'type': 'BACKGROUND', 'citation': 'Biardeau X, Corcos J. Intermittent catheterization in neurologic patients: Update on genitourinary tract infection and urethral trauma. Ann Phys Rehabil Med. 2016 Apr;59(2):125-9. doi: 10.1016/j.rehab.2016.02.006. Epub 2016 Apr 1.'}, {'pmid': '28699993', 'type': 'BACKGROUND', 'citation': 'Fumincelli L, Mazzo A, Martins JCA, Henriques FMD, Orlandin L. Quality of life of patients using intermittent urinary catheterization. Rev Lat Am Enfermagem. 2017 Jul 10;25:e2906. doi: 10.1590/1518-8345.1816.2906.'}, {'pmid': '39261137', 'type': 'BACKGROUND', 'citation': 'Scruggs-Wodkowski E, Kidder I, Meddings J, Patel PK. Urinary Catheter-Associated Infections. Infect Dis Clin North Am. 2024 Dec;38(4):713-729. doi: 10.1016/j.idc.2024.07.006. Epub 2024 Sep 10.'}], 'seeAlsoLinks': [{'url': 'https://www.fda.gov/media/146258/download', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim is to create an electronic patient reported outcome (e-PRO) based registry, specifically for subjects using an intermittent catheter as their primary bladder emptying method.', 'detailedDescription': "The registry's objective is to allow for insights into the needs of people with intimate healthcare needs from the user's perspective and experience. The registry will provide valuable information from the participants' perspective on several issues including, but not limited to product use and satisfaction, frequency of urinary tract infections, and quality-of-life related to IC use. The registry will allow for a more user-centric approach when listening and responding to the needs and challenges of IC users."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals using intermittent catheterization as their primary bladder emptying method will be invited to participate. The initial aim of the registry is to include 1000 users following 18 months after launching the registry in all countries.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to give informed consent\n* 18 years of age or above\n* Full legal capacity\n* Willing and able (self-assessed) to complete online questionnaires\n* using intermittent catheterization as the primary method for bladder emptying'}, 'identificationModule': {'nctId': 'NCT07475468', 'acronym': '382 PRO Panel', 'briefTitle': 'CP382 - Intermittent Catheter (IC) PRO Panel Plan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'CP382 - Intermittent Catheter (IC) PRO Panel Plan', 'orgStudyIdInfo': {'id': 'CP382'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'There is only one observational cohort.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Carri Browne. Clinical Project Manager, BS', 'role': 'CONTACT', 'email': 'dkcarr@coloplast.com', 'phone': '6123235772'}, {'name': 'Ann-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD', 'role': 'CONTACT', 'email': 'dkasib@coloplast.com', 'phone': '+45 49112078'}], 'overallOfficials': [{'name': 'Ann-Sophie Luel-Brockdorff, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Coloplast A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'IQVIA Solutions', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}