Intermittent Catheter for Urinary Issues
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Jessica Simmons
Principal Investigator
Hollister Incorporated
Are You a Good Fit for This Trial?
This trial is for people who use intermittent catheters due to conditions like enlarged prostate, neurogenic bladder, or urinary retention. Participants must already be using this type of catheter and will try a new version to give feedback on its use.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Investigational Intermittent Urinary Catheter
Trial Overview
The study is testing a new intermittent urinary catheter designed with specific features (tip, tube, drainage eyelets). Participants will compare it to their usual catheter and report on comfort, ease of use, and satisfaction.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hollister Incorporated
Lead Sponsor
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