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

NCT03118284 | Terminated

• 1 other identifier: 201609072
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethra Injury; Catheter Site Discomfort

Keywords

Foley catheter

Outcome Measures

Primary Outcomes (1)

• Neutrophil surface marker changes in subjects that experience Foley catheter related bladder discomfort [FCRBD]

  Changes in surface inflammatory markers on polymorphonuclear neutrophils associated with bladder injury secondary to Foley catheter placement.

  Change from baseline [immediately after catheter placement] until catheter removal [post-operative day 1, 2, 3].

Study Arms (2)

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

Interventions

urine collection OTHER

Foley catheter group

Blood collection OTHER

Foley catheter group; Healthy control group

NRS BEHAVIORAL

Foley catheter group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having elective surgery requiring hospitalization and Foley catheter placement.

You may qualify if:

• 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.

You may not qualify if:

• 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
• Urinary tract infection (UTI) as documented by primary team within 24 hours of surgery
• Pregnancy or lactating.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

mtDNA samples isolated from blood and supernatants from urine will be retained and frozen for future research

MeSH Terms

Interventions

Urine Specimen Collection; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Punctures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 18, 2017
• Study Start: November 21, 2016
• Primary Completion: August 21, 2017
• Study Completion: August 28, 2017
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)