Multiple Sclerosis Clinical Trial

GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

Summary

Male self catherterisng observational study.

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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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

45

Study ID:

NCT05470751

Recruitment Status:

Recruiting

Sponsor:

ConvaTec Inc.

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There are 16 Locations for this study

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Kessler Institute for Rehabilitation
West Orange New Jersey, 07052, United States More Info
Todd Linsenmeyer
Principal Investigator
Trustees of The University of Pennsylvania | Penn Urology Washington Square
Philadelphia Pennsylvania, 19106, United States More Info
Diane Newman
Principal Investigator
Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department
Bordeaux , 33076, France More Info
Gregorie Capon
Principal Investigator
Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department
Paris , 75013, France More Info
Emmanuel Chartier-Kastler
Principal Investigator
Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department
Stockport Cheshire, SK2 7, United Kingdom
Broomfield Hospital
Chelmsford Essex, CM1 7, United Kingdom More Info
Martin Nuttall
Principal Investigator
Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development
Southend-on-Sea Essex, SS0 0, United Kingdom More Info
Daben Dawam
Principal Investigator
Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre
Newport Gwent, NP20 , United Kingdom More Info
Karen Logan
Principal Investigator
Southampton General Hospital
Southampton Hampshire, SO16 , United Kingdom More Info
Bhaskar Somani
Principal Investigator
Kent and Canterbury Hospital | Renal Research Delivery Team
Canterbury Kent, CT2 7, United Kingdom More Info
Sashi Kommu
Principal Investigator
Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department
Newcastle Newcastle Upon Tyne, NE7 7, United Kingdom
Sunderland Royal Hospital
Sunderland Tyne & Wear, SR4 7, United Kingdom More Info
Stuart McCracken
Contact
Stuart McCracken
Principal Investigator
North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department
Bristol Westbury-on-Trym, BS10 , United Kingdom More Info
Hashim Hashim
Principal Investigator
Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre
Wakefield Yorkshire, WF1 4, United Kingdom More Info
Wajid Raza
Principal Investigator
Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research
London , SE1 9, United Kingdom More Info
Arun Sahai
Principal Investigator
King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
London , SE5 9, United Kingdom More Info
Nicolas Walker
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

45

Study ID:

NCT05470751

Recruitment Status:

Recruiting

Sponsor:


ConvaTec Inc.

How clear is this clinincal trial information?

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