Foley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells (NCT03118284) | Clinical Trial Compass
TerminatedNot Applicable
Foley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells
Stopped: Principal Investigator is leaving university and halting studies
United States58 participantsStarted 2016-11-21
Plain-language summary
Urinary \[Foley\] catheters \[tubes\] are commonly placed in patients undergoing surgery; approximately 25% of surgical patients will receive one. Among patients who receive urinary catheters, discomfort associated with the Foley catheter is common; between 47-90% of patients experience catheter related bladder discomfort \[CRBD\]. Presence of a foreign object in the bladder even for short periods of time may result in symptoms such as a burning sensation, pain in the lower abdomen, muscle spasms and a sense of urgency to urinate. There is some evidence that suggests that hospital-acquired urinary tract infections are directly related to catheter placement, which causes mechanical damage and local inflammation to the urethra and the bladder. Based on research conducted on a similar mechanism where an airway tube is inserted into a patients throat for delivery of general anesthesia - we hypothesize that CRBD is related to injury and inflammation caused by the catheter placement and that this occurs in a sterile environment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Ages 18 to 75.
✓. American Society of Anesthesiologists Physical Status Classification (ASA) I, II, and III, per CPAP assessment.
✓. Planned Foley catheter placement with surgery and hospitalization.
✓. Scheduled elective surgery (i.e., orthopedic, neurosurgical, spine surgery, cardiac, thoracic surgery, ear nose and throat surgery).
✓. Anticipated length of Foley catheter requirement up to 72 hours.
✓. Ability to provide informed consent.
Exclusion criteria
✕. Visible blood in the urine as evident upon sample collection.
✕. More than one attempt to place the Foley catheter as documented by RN in OR.
✕. Planned surgical procedure involving the urinary system
✕. On dialysis and/or anuric
What they're measuring
1
Neutrophil surface marker changes in subjects that experience Foley catheter related bladder discomfort [FCRBD]
Timeframe: Change from baseline [immediately after catheter placement] until catheter removal [post-operative day 1, 2, 3].