FLUME Catheter Comfort Study

Status unconfirmed

Conditions studied: Urinary Catheters, Bladder Pain and Discomfort, Urine Leakage, Bladder Spasm, Chronic Urinary Catheter, Urinary Retention

In brief

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.

Key facts

Study ID

NCT05785858

Run by

The Flume Catheter Company Ltd

People needed

41

Starts

2023-06-01

Expected to finish

2024-03-30

Last updated by the study team

2023-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Existing catheter related genital adverse effects (e.g., meatal erosion)
• Current use of indwelling catheter larger than 18 Fr in size
• Otherwise unable to participate in or complete study procedures, in the opinion of the principal investigator.

Where it is running

• Penn State Department of Urology — Hershey, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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