Urethra InjuryFCRBDNCT03118284
Foley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells
An observational study of Urethra Injury and Catheter Site Discomfort, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urethra Injury, Catheter Site Discomfort
- What is being tested?
- urine collection, Blood collection and NRS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2016to 28 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having elective surgery requiring hospitalization and Foley catheter placement.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St Louis
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Urethra Injury, Catheter Site Discomfort
- Being tested
- urine collection, Blood collection, NRS
- Keywords
- Foley catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine collectionOther
Blood collectionOther
NRSBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline [immediately after catheter placement] until catheter removal [post-operative day 1, 2, 3].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start21 Nov 2016
- Primary completion21 Aug 2017
- Study completion28 Aug 2017
Why it stopped: Principal Investigator is leaving university and halting studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethra InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118284
- Sponsor's protocol ID
- 201609072
- Acronym
- FCRBD
- Status last verified
- Nov 2018
- First submitted
- 5 Apr 2017
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley Catheter Related Bladder Discomfort (FCRBD): Role of Neutrophil Cells
- ClinicalTrials.gov ID
- NCT03118284
- Acronym / sponsor ID
- FCRBD / 201609072
- Conditions
- Urethra Injury, Catheter Site Discomfort
- Keywords
- Foley catheter
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator is leaving university and halting studies
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 21 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley catheter group | – | Other: urine collection, Other: Blood collection, Behavioral: NRSUrine 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 | – | Other: Blood collectionBlood collection in healthy volunteers from the Research Participant Registry or recruited from posters around the Washington University campus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having elective surgery requiring hospitalization and Foley catheter placement.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine collection | Other | Foley catheter group |
| Blood collection | Other | Foley catheter group, Healthy control group |
| NRS | Behavioural | Foley catheter group |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Principal Investigator is leaving university and halting studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urethra Injury and Catheter Site Discomfort, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator is leaving university and halting studies). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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].). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.