Evaluating the Comfort of a New Catheter Design
FLUME Catheter Comfort Study
This study is testing a new catheter design to see if it makes patients feel more comfortable compared to traditional catheters.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 41 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Flume Catheter Company Ltd Industry-sponsored |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05785858 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the comfort levels of patients using the Flume catheter, which features an innovative design aimed at reducing discomfort associated with traditional Foley catheters. The Flume catheter's balloon envelops the tip upon inflation, minimizing irritation and protecting the bladder lining. Participants will report their comfort levels using validated patient-reported outcome measures, allowing for a comparison between the Flume catheter and traditional catheters. The study aims to gather insights into patient experiences over a three-month period of catheter use.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been using an indwelling urethral catheter for at least three months.
Not a fit: Patients who have had a Foley catheter for less than three months or have certain neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved comfort and quality of life for patients requiring urinary catheters.
How similar studies have performed: While there is existing literature on catheter-related discomfort, this specific design approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hershey, Pennsylvania
- Penn State Department of Urology — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Charles Scales, MD — Duke Clinical Research Institute
- Study coordinator: Tullika Garg, MD
- Email: tgarg@pennstatehealth.psu.edu
- Phone: 717-531-0003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.