Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 4:58 PM
Study NCT ID:
NCT04924569
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-06
First Post:
2021-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continence Care Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D016055', 'term': 'Urinary Retention'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creation of longitudinal continence care ePRO-based, direct-to-consumer registry', 'timeFrame': '5 years', 'description': 'To build a longitudinal continence care ePRO-based, direct-to-consumer registry addressing overall intermittent self-catheterization product satisfaction, QoL, healthcare resource utilization associated with urinary symptoms, urinary tract infections and other complications including burden of ISC over time, and end-user product preference factors.'}], 'secondaryOutcomes': [{'measure': 'Identification of intermittent self-catheterization habits and behaviors', 'timeFrame': '5 years', 'description': 'To identify intermittent self-catheterization habits and behaviors, and enable meaningful intermittent catheter comparisons, including but not limited to product-specific outcomes related to urinary symptoms associated with ISC, frequency of UTI and other complications over time, and product satisfaction over time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intermittent Self Catheterization', 'Intermittent catheter', 'Urinary retention', 'Urinary incontinence', 'Urinary symptoms', 'Urinary tract infection (UTI)'], 'conditions': ['Neurogenic Bladder', 'Non-Neurogenic Bladder']}, 'referencesModule': {'references': [{'pmid': '32999268', 'type': 'BACKGROUND', 'citation': 'New PW. The evidence supporting single-use intermittent catheters in people with spinal cord injury. Spinal Cord Ser Cases. 2020 Sep 30;6(1):89. doi: 10.1038/s41394-020-00339-5.'}, {'pmid': '30051263', 'type': 'BACKGROUND', 'citation': 'Romo PGB, Smith CP, Cox A, Averbeck MA, Dowling C, Beckford C, Manohar P, Duran S, Cameron AP. Non-surgical urologic management of neurogenic bladder after spinal cord injury. World J Urol. 2018 Oct;36(10):1555-1568. doi: 10.1007/s00345-018-2419-z. Epub 2018 Jul 26.'}, {'pmid': '30796114', 'type': 'BACKGROUND', 'citation': 'Letica-Kriegel AS, Salmasian H, Vawdrey DK, Youngerman BE, Green RA, Furuya EY, Calfee DP, Perotte R. Identifying the risk factors for catheter-associated urinary tract infections: a large cross-sectional study of six hospitals. BMJ Open. 2019 Feb 21;9(2):e022137. doi: 10.1136/bmjopen-2018-022137.'}, {'pmid': '31845396', 'type': 'BACKGROUND', 'citation': "Kinnear N, Barnett D, O'Callaghan M, Horsell K, Gani J, Hennessey D. The impact of catheter-based bladder drainage method on urinary tract infection risk in spinal cord injury and neurogenic bladder: A systematic review. Neurourol Urodyn. 2020 Feb;39(2):854-862. doi: 10.1002/nau.24253. Epub 2019 Dec 17."}, {'pmid': '32172456', 'type': 'BACKGROUND', 'citation': 'Newman DK, New PW, Heriseanu R, Petronis S, Hakansson J, Hakansson MA, Lee BB. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol. 2020 Aug;52(8):1443-1451. doi: 10.1007/s11255-020-02435-9. Epub 2020 Mar 14.'}, {'pmid': '28073354', 'type': 'BACKGROUND', 'citation': 'Rognoni C, Tarricone R. Intermittent catheterisation with hydrophilic and non-hydrophilic urinary catheters: systematic literature review and meta-analyses. BMC Urol. 2017 Jan 10;17(1):4. doi: 10.1186/s12894-016-0191-1.'}, {'type': 'BACKGROUND', 'citation': 'Logan, K. Intermittent self-catheterisation in men. Trends Urology & Men Health, 2018;9: 11-14.'}, {'type': 'BACKGROUND', 'citation': 'International Organization for Standardization. Clinical investigation of medical devices for human subjects-Good clinical practice 2011;ISO 14155.'}, {'pmid': '17868186', 'type': 'BACKGROUND', 'citation': 'ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This observational research study aims to build a multinational electronic patient-reported outcomes (ePRO) registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. Research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and other various aspects of using an intermittent catheter.', 'detailedDescription': 'This observational research study aims to build a multinational ePRO registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. Research resulting from data generated from an ePRO registry will factor in end user perspectives on intermittent catheterization habits and behaviors and intermittent catheter performance to inform and guide healthcare providers, end users, and caregivers in making the most informed healthcare decisions regarding intermittent catheterization. Research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and various aspects of habits and behaviors, including health-related quality of life, of using an intermittent catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sponsor-curated customer databases and printed EC/IRB approved advertisements targeted to intermittent catheter consumers from the USA, Canada, UK, Italy, France, Germany, and The Netherlands that may be distributed by clinicians, mail, website, conferences and other consumer contacts.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is at least 18 years of age; male or female.\n2. Is performing transurethral intermittent catheterization.\n3. Uses intermittent catheter(s) from any manufacturer as a form of management for urinary retention or incomplete bladder emptying.\n4. Must be able to provide informed consent and have no cognitive impairment that would hinder the ability to provide informed consent or self-reported data.\n5. Lives and has permanent residence in one of the countries that the study is being conducted at time of enrollment (USA, Canada, UK, Germany, France, The Netherlands, or Italy)\n6. Is willing and able to complete electronic questionnaires monthly for the first year of data collection and quarterly thereafter or appoint a caregiver proxy.\n7. Is able to read and respond to the questionnaires in the language options provided for a given country (e.g. French Canadian or English for Canada)\n\nExclusion Criteria:\n\n1. Performs non transurethral catheterization, e.g., stoma.\n2. Participating in a clinical study involving transurethral intermittent self-catheterization at the time of enrollment.\n3. Employee of Sponsor at the time of enrollment.'}, 'identificationModule': {'nctId': 'NCT04924569', 'acronym': 'ConCaRe™', 'briefTitle': 'Continence Care Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hollister Incorporated'}, 'officialTitle': 'Continence Care Registry (ConCaRe™)', 'orgStudyIdInfo': {'id': '6016-CONT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of Care', 'description': "Individuals using an intermittent catheter to void urine through the urethra. Participants use their currently prescribed intermittent catheter per their clinician's standard of care."}]}, 'contactsLocationsModule': {'locations': [{'zip': '60048', 'city': 'Libertyville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hollister Incorporated', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}], 'overallOfficials': [{'name': 'Jessica Simmons, DNP, APRN, FNP-C, CWON, DNC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hollister Incorporated'}, {'name': 'Diane Newman, D.N.P. F.A.A.N. B.C.B.-P.M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hollister Incorporated', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}, {'name': 'Technomics Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}