FLUME Catheter Comfort Study
Unknown statusNCT05785858
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- FLUME Catheter Comfort Study
- Conditions
- Urinary Catheters
- Bladder Pain and Discomfort
- Urine Leakage
- Bladder Spasm
- Chronic Urinary Catheter
- Urinary Retention
- Sponsor
- The Flume Catheter Company Ltd
- Collaborators
- Duke Clinical Research Institute; Milton S. Hershey Medical Center
- Start date
- 2023-06-01
- Primary completion
- 2024-03-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05785858