FLUME Catheter Comfort Study

Launched by THE FLUME CATHETER COMPANY LTD · Mar 14, 2023

Keywords

ClinConnect Summary

The FLUME Catheter Comfort Study is looking at a new type of urinary catheter called the Flume catheter, designed to improve comfort for patients who need to use a catheter for a long time. Unlike traditional catheters that have a protruding tip, which can cause pain and discomfort, the Flume catheter has a unique design where the balloon surrounds the tip when inflated. This design aims to reduce discomfort and bladder spasms. The study will compare the comfort levels of patients using the Flume catheter to those using regular catheters.

To join the study, participants must be at least 18 years old and have been using a catheter for at least three months. They also need to be able to read, write, and speak English. During the study, participants will provide feedback on how comfortable they feel with the Flume catheter. The study is currently recruiting participants, and everyone is welcome to apply, regardless of gender. If you or someone you know has been using a catheter for a while and wants to help improve comfort for others, this study might be a great opportunity!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Document informed consent
• • 2. Age ≥ 18 years at time of study entry
• • 3. Indwelling urethral catheter use for at least the 3 months prior to study enrollment.
• • 4. Able to read, write, and speak English
• Exclusion Criteria:
• • 1. Indwelling Foley catheter user for shorter than 3 months
• • 2. Treatment for a urinary tract infection within 30 days prior to insertion of the Flume catheter, or reporting signs or symptoms of urinary tract infection at the time of catheter change, in the opinion of the treating clinician or site principal investigator.
• • 3. Unable to read/write English at a 6th grade level
• • 4. Neurologic diagnoses which could decrease/impair bladder sensation (e.g., spinal cord injury, multiple sclerosis)
• • 5. History of bladder augmentation or urinary diversion
• • 6. Existing catheter related genital adverse effects (e.g., meatal erosion)
• • 7. Current use of indwelling catheter larger than 18 Fr in size
• • 8. Otherwise unable to participate in or complete study procedures, in the opinion of the principal investigator.