Research Study on Comfort of the New FLUME Catheter to Begin Recruitment – Press Release

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Duke Clinical Research Institute and Penn State College of Medicine Partner to Collect Patient Insight on Innovative FLUME Catheter

The Flume Catheter Company Ltd. (TFCC), a medical device company dedicated to developing an improved alternative to the Foley indwelling urinary catheter, announced the launch of a study to gather real-world data on patient experiences with the new FLUME catheter.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230428005097/en/

The FLUME catheter, which received clearance in November 2021 from the U.S. Food and Drug Administration (FDA), is designed to address some of the triggers that can negatively impact patients’ comfort and quality of life.

The FLUME catheter is distinguished by an alternative balloon configuration, designed to envelop the tip of the catheter upon inflation and, thereby, allow the emptying bladder to come into contact with the compliant balloon rather than a rigid catheter tip. The drainage holes are inset low in the balloon, designed to enhance bladder drainage as well as guard against bladder mucosa being drawn into the drainage holes.

Researchers at Duke Clinical Research Institute and Penn State College of Medicine have formed a strategic partnership to conduct the study and obtain first-hand information from patients with indwelling catheters. Participants will provide their feedback before and after using the FLUME catheter for up to 30 days, which will allow researchers to assess patients’ perceptions around comfort and quality of life factors with their traditional catheters and with the new FLUME catheter.

“The innovative FLUME design eliminates the exposed catheter tip, which has been a feature of nearly all urethral catheters since Dr. Foley’s original model in the 1930’s,” said Charles Scales, M.D., FLUME Catheter Comfort Study Principal Investigator, and associate professor of Surgery in the Division of Urology at Duke…

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