About this trial
This clinical study is designed to evaluate the initial safety and performance of an investigational intermittent urinary catheter in people who use intermittent catheterization. Participants will use the study catheter and provide feedback on their experience, including ease of insertion, advancement through the urethra, bladder drainage, withdrawal, comfort, confidence, satisfaction, and overall ease of use.
Safety will be evaluated through reported health changes and adverse events. Device performance and user experience will be assessed using participant questionnaires and comparisons with the participant's current intermittent catheter, including questions related to catheter handling, comfort during catheterization, perceived ability to empty the bladder, likelihood of future use, and product preference.
The study is intended to generate descriptive information on the initial clinical use of the investigational catheter and to help characterize its safety, usability, comfort, satisfaction, and performance relative to participants' current intermittent catheter products.
Eligibility criteria
Qualifiers
is living in the USA
is male
is at least 22 years of age
can speak, read, and write in English
Disqualifiers
is currently receiving chemotherapy, has received chemotherapy within the past 30 days, or is scheduled to receive chemotherapy during the study (i.e., in the next 34 days)
is currently undergoing, has previously underwent, or is planning to undergo radiation therapy to the bladder, prostate, or rectum during the study (i.e., in the next 34 days)
Acthar Gel
corticotropin
Trial design
Treatments tested in this trial
- An intermittent urethral urinary catheter with a tip, tube and drainage eyelets