CompletedNot Applicable

GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

United States, France, United Kingdom72 participantsStarted 2023-02-02

Plain-language summary

Male self catherterisng observational study.

Who can participate

Age range

18 Years – 100 Years

Sex

MALE

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 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation

Timeframe: 60 days

Trial details

NCT IDNCT05470751

SponsorConvaTec Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-06

View on ClinicalTrials.gov More Bladder Outlet Obstruction trials