FLUME Catheter Comfort Study

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

FLUME Catheter Comfort Study

FLUME Catheter Comfort Study

Condition
Urinary Catheters
Intervention / Treatment

-

Contacts and Locations

Hershey

Penn State Department of Urology, Hershey, Pennsylvania, United States, 17033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Flume Catheter Company Ltd,

Charles Scales, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

2024-03-30