GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
NCT ID: NCT05470751
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2023-02-02
2024-04-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Intermittent self-catheterisation
Self-catheterising with GC Male and Glide Male with Feelclean technology
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
MALE
No
Sponsors
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ConvaTec Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Harding
Role: PRINCIPAL_INVESTIGATOR
Site Investigator - Newcastle
Locations
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Kessler Institute for Rehabilitation
West Orange, New Jersey, United States
Trustees of The University of Pennsylvania | Penn Urology Washington Square
Philadelphia, Pennsylvania, United States
Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department
Bordeaux, , France
Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department
Paris, , France
Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department
Stockport, Cheshire, United Kingdom
Broomfield Hospital
Chelmsford, Essex, United Kingdom
Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development
Southend-on-Sea, Essex, United Kingdom
Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre
Newport, Gwent, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Kent and Canterbury Hospital | Renal Research Delivery Team
Canterbury, Kent, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department
Newcastle, Newcastle Upon Tyne, United Kingdom
Sunderland Royal Hospital
Sunderland, Tyne & Wear, United Kingdom
North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department
Bristol, Westbury-on-Trym, United Kingdom
Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre
Wakefield, Yorkshire, 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
Countries
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Other Identifiers
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CC-21-425
Identifier Type: -
Identifier Source: org_study_id
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