Multiple Sclerosis Clinical Trial
GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
Summary
Male self catherterisng observational study.
Full Description
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.
Difficulty 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.
Patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection will also be recorded.
Eligibility Criteria
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
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There are 16 Locations for this study
West Orange New Jersey, 07052, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19106, United States More Info
Principal Investigator
Bordeaux , 33076, France More Info
Principal Investigator
Paris , 75013, France More Info
Principal Investigator
Stockport Cheshire, SK2 7, United Kingdom
Chelmsford Essex, CM1 7, United Kingdom More Info
Principal Investigator
Southend-on-Sea Essex, SS0 0, United Kingdom More Info
Principal Investigator
Newport Gwent, NP20 , United Kingdom More Info
Principal Investigator
Southampton Hampshire, SO16 , United Kingdom More Info
Principal Investigator
Canterbury Kent, CT2 7, United Kingdom More Info
Principal Investigator
Newcastle Newcastle Upon Tyne, NE7 7, United Kingdom
Sunderland Tyne & Wear, SR4 7, United Kingdom More Info
Contact
Principal Investigator
Bristol Westbury-on-Trym, BS10 , United Kingdom More Info
Principal Investigator
Wakefield Yorkshire, WF1 4, United Kingdom More Info
Principal Investigator
London , SE1 9, United Kingdom More Info
Principal Investigator
London , SE5 9, United Kingdom More Info
Principal Investigator
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