NCT05470751Completed
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
Source: ClinicalTrials.gov · Last updated 30 Apr 2024
Brief summary (registry, in English)
Male self catherterisng observational study.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 72 (actual)
- First submitted
- 20 Jul 2022
- Start date
- 2 Feb 2023
- Primary completion date
- 6 Apr 2024
- Lead sponsor
- ConvaTec Inc.
- Diseases
- Parkinson disease, Multiple sclerosis
- NCT number
- NCT05470751
What you commit to
- Study type: Observational
- Participants enrolled: 72
- From 2 Feb 2023 to the primary completion date, 6 Apr 2024
- 16 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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
Who the study is looking for
- • 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Kent and Canterbury Hospital | Renal Research Delivery Team Coordinator of this site? Confirm its status | Canterbury | United Kingdom | Unknown status |
| Broomfield Hospital Coordinator of this site? Confirm its status | Chelmsford | United Kingdom | Unknown status |
| King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre Coordinator of this site? Confirm its status | Newport | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development Coordinator of this site? Confirm its status | Southend-on-Sea | United Kingdom | Unknown status |
| Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department Coordinator of this site? Confirm its status | Stockport | United Kingdom | Unknown status |
| Sunderland Royal Hospital Coordinator of this site? Confirm its status | Sunderland | United Kingdom | Unknown status |
| Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre Coordinator of this site? Confirm its status | Wakefield | United Kingdom | Unknown status |
| Trustees of The University of Pennsylvania | Penn Urology Washington Square Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Kessler Institute for Rehabilitation Coordinator of this site? Confirm its status | West Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.