FLUME Catheter Comfort Study (NCT05785858) | Clinical Trial Compass
UnknownNot Applicable
FLUME Catheter Comfort Study
United States41 participantsStarted 2023-06-01
Plain-language summary
The Flume catheter is a commercially available (FDA 510(k) cleared) urethral catheter with an innovative catheter design. The traditional Foley catheter design includes a protruding tip with drainage holes. The protruding tip may contribute to patient discomfort, pain and bladder spasms. The Flume catheter is designed such that the balloon envelops the tip on inflation, thus eliminating the protruding catheter tip, while the drainage holes are inset low in the balloon, providing protection to the bladder lining. Based on the change in design, the hypothesis of this observational cohort study is the Flume catheter will have better patient comfort scores (using validated patient reported outcomes measures) when compared to a traditional catheter.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Document informed consent
✓. Age ≥ 18 years at time of study entry
✓. Indwelling urethral catheter use for at least the 3 months prior to study enrollment.
✓. Able to read, write, and speak English
Exclusion criteria
✕. Indwelling Foley catheter user for shorter than 3 months
✕. 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.
✕. Unable to read/write English at a 6th grade level
✕. Neurologic diagnoses which could decrease/impair bladder sensation (e.g., spinal cord injury, multiple sclerosis)
✕. History of bladder augmentation or urinary diversion
✕
What they're measuring
1
Change in patient reported outcomes--Total Neurogenic Bladder Symptom Score Short Form