Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT05470751
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2022-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001748', 'term': 'Urinary Bladder Neck Obstruction'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D000077684', 'term': 'Cauda Equina Syndrome'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D000077295', 'term': 'Urinary Bladder, Underactive'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014524', 'term': 'Urethral Obstruction'}, {'id': 'D014522', 'term': 'Urethral 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': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2022-07-20', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation', 'timeFrame': '60 days', 'description': 'To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q'}], 'secondaryOutcomes': [{'measure': 'To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection', 'timeFrame': '60 days', 'description': 'To assess patient confidence regarding reduced stickiness plus related risk of urethral'}, {'measure': 'To assess compliance with the self-catheterization for the study duration', 'timeFrame': '60 days', 'description': 'To assess compliance with the self-catheterization for the study duration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurogenic bladder', 'intermittent self-catherterisation', 'pain', 'bladder outflow obstruction'], 'conditions': ['Bladder Outlet Obstruction', 'Multiple Sclerosis', 'Cauda Equina Syndrome', 'Enlarged Prostate With Lower Urinary Tract Symptoms', 'Parkinson Disease', 'Lower Urinary Tract Symptoms', 'Detrusor Underactivity', 'Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'Male self catherterisng observational study.', 'detailedDescription': 'This is a multicentre, prospective international observational study. Male patients in the UK, USA and France performing self-catheterisation will be asked to participate in this study. The subjects will be asked to use the GentleCath™ Intermittent Catheter with FeelClean™ Technology as per their normal routine. They will be asked to record when and where they catheterise. At the baseline, during and on completion of the study, the subjects will be asked to complete Difficulty in Catheterisation plus Intermittent Catheter related Quality of Life Questionnaires.\n\nDifficulty during catheterisation and quality of life will be assessed using the ICDQ and ISC-Q validated questionnaires during catheterisation at the start of the study before use of GentleCath™ Air has commenced (D0) and on day 1 (D1), day 15 (D15), day 30 (D30), day 45 (D45) and day 60 (D60) transcribed in a collecting record provided for this purpose. Compliance and catheter use will also be assessed.\n\nPatient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection will also be recorded.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult males who self-catheterise', 'genderDescription': 'Must be able to insert catheter into a penile urethra', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Adult male (aged 18 years and over)\n\n * Diagnosed with a neurological lower urinary tract dysfunction due to either spinal cord injury, Multiple Sclerosis, Parkinson's Syndrome, Cauda equina syndrome Or Diagnosed with bladder outflow obstruction secondary to benign prostate enlargement Or Diagnosed with detrusor underactivity\n * Performing single use clean intermittent self-catheterisation (ISC) at least twice a day\n * Willing to undergo training with GC Trainer video prior to use of catheter\n * Provided fully informed consent and has sufficient understanding of English or French\n * Sufficient dexterity to use GentleCath™ Air for Men intermittent including ability to open packaging\n * Intact urethral sensation of catheterisation\n * Willing to use only the GentleCath™ Air intermittent catheter for the full duration of the study (60-days)\n * Subject has a valid email address so the Investigator can send links to study questionnaires and the subject has access to a web enabled device\n\nExclusion Criteria:\n\n* • Participation in another related urological study\n\n * Unable to perform ISC unaided\n * Already prescribed the GentleCath™ Air Intermittent Catheter\n * Absent urethral or perineal sensation\n * Unwilling to undergo training with GC Trainer prior to use of catheter\n * Insufficient dexterity to use GentleCath™ Air Intermittent Catheter and or packaging\n * Suffering from a symptomatic UTI (Urinary Tract Infections) at the time of inclusion or in the preceding 6-weeks\n * Undergoing surgical treatment during the period of the study\n * Performing catheterisation for urethral stricture"}, 'identificationModule': {'nctId': 'NCT05470751', 'briefTitle': 'GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology', 'organization': {'class': 'INDUSTRY', 'fullName': 'ConvaTec Inc.'}, 'officialTitle': 'A Multi-centre Prospective Observational Study of the User Experience of Catheterisation and Quality of Life in Patients Prescribed GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology', 'orgStudyIdInfo': {'id': 'CC-21-425'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intermittent self-catheterisation', 'type': 'DEVICE', 'description': 'Self-catheterising with GC Male and Glide Male with Feelclean technology'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Institute for Rehabilitation', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}, {'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Trustees of The University of Pennsylvania | Penn Urology Washington Square', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'SK2 7JE', 'city': 'Stockport', 'state': 'Cheshire', 'country': 'United Kingdom', 'facility': 'Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department', 'geoPoint': {'lat': 53.40979, 'lon': -2.15761}}, {'zip': 'CM1 7ET', 'city': 'Chelmsford', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Broomfield Hospital', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}, {'zip': 'SS0 0RY', 'city': 'Southend-on-Sea', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development', 'geoPoint': {'lat': 51.53782, 'lon': 0.71433}}, {'zip': 'NP20 2UB', 'city': 'Newport', 'state': 'Gwent', 'country': 'United Kingdom', 'facility': 'Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre', 'geoPoint': {'lat': 51.58774, 'lon': -2.99835}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'CT2 7FG', 'city': 'Canterbury', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Kent and Canterbury Hospital | Renal Research Delivery Team', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'zip': 'NE7 7DN', 'city': 'Newcastle', 'state': 'Newcastle Upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'SR4 7TP', 'city': 'Sunderland', 'state': 'Tyne & Wear', 'country': 'United Kingdom', 'facility': 'Sunderland Royal Hospital', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'state': 'Westbury-on-Trym', 'country': 'United Kingdom', 'facility': 'North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'WF1 4DG', 'city': 'Wakefield', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Chris Harding', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Site Investigator - Newcastle'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ConvaTec Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}