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NCT03118284 · ClinicalTrials.gov registry record
Foley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells
A clinical trial, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- 58
- Enrollment target
NCT03118284: Clinical Trial study, sponsored by Washington University School of Medicine.
NCT03118284 is a clinical trial that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 58 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03118284 was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- 58 participants
- Enrollment target
Study 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.
Primary Outcome
Changes in surface inflammatory markers on polymorphonuclear neutrophils associated with bladder injury secondary to Foley catheter placement.
Interventions
- OTHER Blood collection
- OTHER urine collection
- BEHAVIORAL NRS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2017-08-28 |
Why NCT03118284 stopped before completion
NCT03118284 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 58 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Blood collection is the first listed.
NCT03118284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03118284 about?
NCT03118284 is a clinical study titled "Foley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells". 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 rel...
What is the current status of trial NCT03118284?
This trial is currently terminated. The enrollment target is 58 participants. The study started on 2016-11-21. Estimated completion is 2017-08-28.
What interventions are being tested in trial NCT03118284?
The interventions under investigation include: Blood collection (OTHER), urine collection (OTHER), NRS (BEHAVIORAL).
Who is sponsoring clinical trial NCT03118284?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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