Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05470751
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05470751
Study Brief:
Protocol Section:
NCT05470751