Multiple Sclerosis Clinical Trial
Official title:
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
NCT number | NCT05470751 |
Other study ID # | CC-21-425 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2, 2023 |
Est. completion date | April 6, 2024 |
Verified date | April 2024 |
Source | ConvaTec Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Male self catherterisng observational study.
Status | Completed |
Enrollment | 72 |
Est. completion date | April 6, 2024 |
Est. primary completion date | April 6, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - • Adult male (aged 18 years and over) - 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 - Performing single use clean intermittent self-catheterisation (ISC) at least twice a day - Willing to undergo training with GC Trainer video prior to use of catheter - Provided fully informed consent and has sufficient understanding of English or French - Sufficient dexterity to use GentleCath™ Air for Men intermittent including ability to open packaging - Intact urethral sensation of catheterisation - Willing to use only the GentleCath™ Air intermittent catheter for the full duration of the study (60-days) - 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 Exclusion Criteria: - • Participation in another related urological study - Unable to perform ISC unaided - Already prescribed the GentleCath™ Air Intermittent Catheter - Absent urethral or perineal sensation - Unwilling to undergo training with GC Trainer prior to use of catheter - Insufficient dexterity to use GentleCath™ Air Intermittent Catheter and or packaging - Suffering from a symptomatic UTI (Urinary Tract Infections) at the time of inclusion or in the preceding 6-weeks - Undergoing surgical treatment during the period of the study - Performing catheterisation for urethral stricture |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department | Bordeaux | |
France | Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department | Paris | |
United Kingdom | North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department | Bristol | Westbury-on-Trym |
United Kingdom | Kent and Canterbury Hospital | Renal Research Delivery Team | Canterbury | Kent |
United Kingdom | Broomfield Hospital | Chelmsford | Essex |
United Kingdom | Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research | London | |
United Kingdom | King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department | London | |
United Kingdom | Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department | Newcastle | Newcastle Upon Tyne |
United Kingdom | Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre | Newport | Gwent |
United Kingdom | Southampton General Hospital | Southampton | Hampshire |
United Kingdom | Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development | Southend-on-Sea | Essex |
United Kingdom | Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department | Stockport | Cheshire |
United Kingdom | Sunderland Royal Hospital | Sunderland | Tyne & Wear |
United Kingdom | Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre | Wakefield | Yorkshire |
United States | Trustees of The University of Pennsylvania | Penn Urology Washington Square | Philadelphia | Pennsylvania |
United States | Kessler Institute for Rehabilitation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
ConvaTec Inc. |
United States, France, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation | To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q | 60 days | |
Secondary | To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection | To assess patient confidence regarding reduced stickiness plus related risk of urethral | 60 days | |
Secondary | To assess compliance with the self-catheterization for the study duration | To assess compliance with the self-catheterization for the study duration | 60 days |
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