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.
Inclusion Criteria:
is living in the USA
is male
is at least 22 years of age
can speak, read, and write in English
is self-catheterizing 3 or more times a day
has been performing unassisted, self-catheterizations, with a Hydrophilic IC, for at least 1 month
currently uses one of the hydrophilic ICs (length=40cm; size=Ch. 14) listed below:
is willing and able to follow the study protocol procedures including completing online questionnaires as demonstrated by signing the Informed Consent
is willing to switch from their current, typical intermittent catheter to the study-provided study products (e.g., study catheters) during the latter portion of the study
is willing to provide permission via the study informed consent and HIPAA Authorization Form for study staff to contact prescribing healthcare provider for a copy of their active prescription. Alternatively subject can opt to provide study staff with their active prescription.
Exclusion Criteria:
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)
is currently using one or more of the following oral or injectable steroid therapies for 30 days or more:
currently has urinary tract infection (UTI) symptoms or has been diagnosed with a UTI by a healthcare provider in the last 2 weeks
has a retracted penis
has skin irritation or lesions (sores) on the penis
Performs non-urethral catheterization
Has participated in a study involving actual use of a study urethral IC (i.e. inserting/removing) within the last 30 days
Is currently an employee of Hollister Incorporated or any other intermittent catheter manufacturer.
Participants will first use 30 of their usual intermittent catheters and then switch to 30 study catheters in a fixed-sequence, within-participant design. All participants receive the same study catheter; responses from the usual-catheter period provide within-participant control context.
Libertyville, Illinois 60048, United States
researchstudy@hollister.com(847) 680-1000
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