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FLUME Catheter Comfort Study

NCT05785858 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2023-09-13

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • Milton S. Hershey Medical Center

    collaborator OTHER

  • The Flume Catheter Company Ltd

    lead INDUSTRY

Principal Investigators

  • Charles Scales, MD · Duke Clinical Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-03-30
Completion
2024-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05785858 on ClinicalTrials.gov