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Foley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells (FCRBD)

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ClinicalTrials.gov Identifier: NCT03118284
Recruitment Status : Terminated (Principal Investigator is leaving university and halting studies)
First Posted : April 18, 2017
Last Update Posted : November 15, 2018
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment
Urethra Injury Catheter Site Discomfort Other: urine collection Other: Blood collection Behavioral: NRS

Detailed Description:

Urinary catheterization has been implicated in up to 80% of hospital-acquired UTIs, and has been associated with evidence for immunological and histological damage frequently in the absence of bacteria31. In a recent human study in elderly patients with ASB and UTI analysis of neutrophil activity showed evidence of enzymatic involvement during bladder infection32, and some appeared to relate to pain and inflammation, however no analysis was conducted regarding neutrophil phenotypes and the impact of mtDNA on sterile local injury mediated exclusively by a Foley catheter.

The bladder irritation that results from Foley catheterization appears to be mediated by muscarinic receptors that mediate involuntary bladder smooth-muscle contractility. Thus the main therapy relies on agents with anti-muscarinic activity such as oxybutynin, tolterodine and butylscopolamine, whereas some benefit has been shown with tramadol, ketamine, paracetamol, pregabalin and gabapentin. However no single commonly accepted therapy for FCRBD is available, and there is uncertainty about the safety and efficacy of the current treatments available. Some research has suggested a role for inflammatory mediators in the occurrence of FCRBD as evident by induction of prostaglandin synthesis and cyclooxygenase-2 (COX-2) inhibitors alleviating symptoms related to FCRBD. In summary various therapies to control FCRBD are available but none have directly addressed the acute inflammatory reaction likely mediating these symptoms1,2,3,4. Hence our interest in analyzing the activity of acute inflammatory cells in particular neutrophil activation as a mediator of bladder inflammation and trigger of FCRBD.

Although the exact pathophysiology of FCRBD has not been elucidated, we recently showed expression of inflammatory mediators, neutrophil infiltration and mucosal surface injury in the absence of bacterial infection using a human model of tracheal injury. As it has been clearly shown that neutrophil infiltration and activation can be driven in response to sterile cell death8, our preliminary data suggest that the link between Foley catheter and possible bladder neutrophil accumulation is through mucosal cell injury.

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Foley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells
Actual Study Start Date : November 21, 2016
Actual Primary Completion Date : August 21, 2017
Actual Study Completion Date : August 28, 2017

Group/Cohort Intervention/treatment
Foley catheter group
Urine collection and blood collection and NRS for pain in patients having surgery for which their surgeon has ordered placement of a Foley catheter.
Other: urine collection
Other: Blood collection
Behavioral: NRS
Healthy control group
Blood collection in healthy volunteers from the Research Participant Registry or recruited from posters around the Washington University campus
Other: Blood collection

Primary Outcome Measures :
  1. Neutrophil surface marker changes in subjects that experience Foley catheter related bladder discomfort [FCRBD] [ Time Frame: Change from baseline [immediately after catheter placement] until catheter removal [post-operative day 1, 2, 3]. ]
    Changes in surface inflammatory markers on polymorphonuclear neutrophils associated with bladder injury secondary to Foley catheter placement.

Biospecimen Retention:   Samples With DNA
mtDNA samples isolated from blood and supernatants from urine will be retained and frozen for future research

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having elective surgery requiring hospitalization and Foley catheter placement.

Inclusion Criteria:

  1. Ages 18 to 75.
  2. American Society of Anesthesiologists Physical Status Classification (ASA) I, II, and III, per CPAP assessment.
  3. Planned Foley catheter placement with surgery and hospitalization.
  4. Scheduled elective surgery (i.e., orthopedic, neurosurgical, spine surgery, cardiac, thoracic surgery, ear nose and throat surgery).
  5. Anticipated length of Foley catheter requirement up to 72 hours.
  6. Ability to provide informed consent.

Exclusion Criteria:

  1. Visible blood in the urine as evident upon sample collection.
  2. More than one attempt to place the Foley catheter as documented by RN in OR.
  3. Planned surgical procedure involving the urinary system
  4. On dialysis and/or anuric
  5. Urinary tract infection (UTI) as documented by primary team within 24 hours of surgery
  6. Pregnancy or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118284

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United States, Missouri
Washington University in St Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03118284    
Other Study ID Numbers: 201609072
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Foley catheter