GentleCathâ„¢ for Men Intermittent Catheter With FeelCleanâ„¢ Technology (NCT05470751) | Clinical Trial Compass
CompletedNot Applicable
GentleCathâ„¢ for Men Intermittent Catheter With FeelCleanâ„¢ Technology
United States, France, United Kingdom72 participantsStarted 2023-02-02
Plain-language summary
Male self catherterisng observational study.
Who can participate
Age range18 Years – 100 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 GentleCathâ„¢ Air for Men intermittent including ability to open packaging
* Intact urethral sensation of catheterisation
* Willing to use only the GentleCathâ„¢ 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 GentleCathâ„¢ Air Intermittent Catheter
* Absent urethral or perineal sensation
* Unwilling to undergo training with GC Trainer prior to use of catheter
* Insufficient dexterity to use GentleCathâ„¢ Air Intermittent Catheter and or packaging
* Suffering from a symptomatic UTI (Urinary Tract Infections) at the time of inclusion …
What they're measuring
1
To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation