GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
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
1 other identifier
observational
72
3 countries
16
Brief Summary
Male self catherterisng observational study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2023
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedStudy Start
First participant enrolled
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2024
CompletedApril 30, 2024
April 1, 2024
1.2 years
July 20, 2022
April 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection
60 days
To assess compliance with the self-catheterization for the study duration
60 days
Interventions
Self-catheterising with GC Male and Glide Male with Feelclean technology
Eligibility Criteria
Adult males who self-catheterise
You may qualify if:
- 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
You may not qualify if:
- 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
- Undergoing surgical treatment during the period of the study
- Performing catheterisation for urethral stricture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ConvaTec Inc.lead
Study Sites (16)
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052, United States
Trustees of The University of Pennsylvania | Penn Urology Washington Square
Philadelphia, Pennsylvania, 19106, United States
Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department
Bordeaux, 33076, France
Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department
Paris, 75013, France
Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department
Stockport, Cheshire, SK2 7JE, United Kingdom
Broomfield Hospital
Chelmsford, Essex, CM1 7ET, United Kingdom
Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development
Southend-on-Sea, Essex, SS0 0RY, United Kingdom
Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre
Newport, Gwent, NP20 2UB, United Kingdom
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Kent and Canterbury Hospital | Renal Research Delivery Team
Canterbury, Kent, CT2 7FG, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department
Newcastle, Newcastle Upon Tyne, NE7 7DN, United Kingdom
Sunderland Royal Hospital
Sunderland, Tyne & Wear, SR4 7TP, United Kingdom
North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department
Bristol, Westbury-on-Trym, BS10 5NB, United Kingdom
Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre
Wakefield, Yorkshire, WF1 4DG, United Kingdom
Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research
London, SE1 9RT, United Kingdom
King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Harding
Site Investigator - Newcastle
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
July 22, 2022
Study Start
February 2, 2023
Primary Completion
April 6, 2024
Study Completion
April 6, 2024
Last Updated
April 30, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share