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

ID: NCT03118284
Status: Recruiting
Phase: N/A
Start Date: October 31, 2016
First Submitted: April 05, 2017
Last Updated: February 19, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Urethra Injury, Catheter Site Discomfort
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Study Description

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.

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.
Condition or disease Intervention/treatment Phase

Catheter Site Discomfort

Urethra Injury

Other: urine collection
Other Names
Other: Blood collection
Other Names
Behavioral: NRS
Other Names
N/A

Tracking Information

First Submitted DateApril 05, 2017
Last Update Posted DateFebruary 19, 2018
Actual Start DateOctober 31, 2016
Anticipated Completion DateMarch 31, 2019
Actual Primary Completion DateJanuary 31, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleFoley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells
Official TitleFoley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells
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.

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.

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
120
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Catheter Site Discomfort
Urethra Injury
Target Follow-Up Duration N/A
Biospecimen:
Retention: Samples With DNA
Description: mtDNA samples isolated from blood and supernatants from urine will be retained and frozen for future research
Sampling MethodNon-Probability Sample
Study PopulationPatients having elective surgery requiring hospitalization and Foley catheter placement.
Intervention
Other: urine collection

Other Names
Other: Blood collection

Other Names
Behavioral: NRS

Other Names
Study Groups/Cohorts
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.

Healthy control group
Blood collection in healthy volunteers from the Research Participant Registry or recruited from posters around the Washington University campus

Study Arms
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

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 : Blood collection

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.
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

Arm 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
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 : Blood collection
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.
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

Recruitment Information

Recruitment Status:Recruiting
Enrollment120
Completion DateMarch 31, 2019
Eligibility Criteria: 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.
GenderAll
Age18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03118284
Other Study ID Numbers
201609072
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Not Available