We are seeking premenopausal women age 30 to 50 who experience moderate to severe incontinence. This is a home based trial and participants must reside in the state of Florida. This clinical trial is designed to last 20 to 60 days depending on results and participant desire to continue. Clinical Trial is planned for 2025/2026. Please check back for updates.
CAUTIBarrier is designed to block bacteria that commonly cause infections from indwelling long-term catheter use. If you are experienced with self catheterization you may be ideal for this clinical trail.
While there is no compensation for this home based trial, you may save on the cost of absorbable undergarments during the time of the trial. Freedom from adult diapers may make participation worthwhile as well. The other important benefit is helping to move a concept forward that may help millions of women and men avoid CAUTI infections, providing cost effective healthcare options and better quality of life.
We provide everything required including a medical consultant, self-catheterization training protocol, the necessary catheter and accessories.
Participants will self-catheterize a single time in a CAUTI protocol based, sterile procedure. This will include completing the CAUTIBarrier hypoallergenic sterile seal.
Indwelling catheter users often describe the feeling as a light pressure on the bladder as if a light need for urination. For participant awake hours, plan for "self managed" bladder release every two hours getting started then adjust schedule for your personal needs. Self managed release is as simple as sitting on a toilet and releasing the catheter end cap allowing your bladder to empty from natural and bladder muscle pressure. Participant sleeping hours will require a closed system collection bag that will also be provided.
Participation timeframe will be 20 to 60 days based on participant comfort level, daily reporting results and desire to continue.
Daily self inspections of the catheter and surrounding area are required with daily online reporting on your experience, comfort and vitals. We provide easy to use, secure website for daily reporting. Weekly phone medical check in appointments are also required.
• Premenopausal woman age 30 to 50 experiencing moderate to severe incontinence.
• Are you relient of absorbable underpads?
• Do you self-catheterize or what is your comfort level with self-catheterization?
• Ability to report daily on your experience and vitals online to a secure website?
• Availability for a phone based weekly medical check in?
• Do you reside full time in the state of Florida?
• You decide when and how to use the bathroom.
• No more embarrassing urine odors.
• No sitting in wet, irritating undergarments.
• No more disposal of saturated pads.
• Wear the clothing you want wear.
• SAVE $$$ on expensive undergarments.
Thanks for your interest. Clinical trial anticipated late 2025 or early 2026.
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