Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection

Urinary Tract Infection (UTI) is the most common hospital acquired infection worldwide, and is most commonly associated with catheterisation of the bladder. Catheter associated urinary tract infection (CAUTI) causes increased hospital costs, increased length of stay and increased mortality. This burden of disease is, in part, mediated by a lack of diagnostic and monitoring modalities for CAUTI. Both traditional and novel UTI diagnostic tests are susceptible to false positives associated with bacterial colonisation, and correlate poorly with clinically meaningful symptomatic CAUTI. As such, the current standard of care is reliant on clinical monitoring, which is susceptible to diagnostic delays, over and under treatment.

Imperial College London have developed a wireless biosensor for continuous monitoring of catheter-urine biochemistry. This project aims to validate this biosensor and demonstrate it's potential for preemptive CAUTI diagnosis through continuous urinary biochemical monitoring.

Study Overview

• Status: Completed
• Conditions: Catheter-Associated Urinary Tract Infection
• Intervention / Treatment: Diagnostic test: Smart Catheter Biosensor

Detailed Description

This research project aims to demonstrate that continuous urinary biochemical monitoring using a Smart Catheter biosensor can provide rapid diagnosis of impending catheter associated urinary tract infection (CAUTI). The primary research question will then be: "Does the Smart Catheter device reduce the time to diagnosis of CAUTI?"

This will be accomplished through four studies: The aim of the first study will be to show the reliability and robustness of the Smart Catheter device through the question: "Is there any difference between the biochemical measurements from the Smart catheter device and a gold-standard laboratory measurement?"

The aim of the second and third studies aim to demonstrate the different biochemical profiles of infected and healthy urine by addressing the research question: "What is the difference in biochemical concentrations in healthy urine as compared to infected urine?" Study 3 will accomplish this by comparing infected human catheter-acquired urine as compared to uninfected human catheter-urine. Study 3 will monitor the changes in biochemical changes in an artifical bladder with artificial urine over time while an infection is induced.

The final study will demonstrate the reduced time to diagnosis in a clinical setting by addressing the research question: " What is the time difference in diagnosis of CAUTI from the CAUTI as compared to the current standard of clinical monitoring?"

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater LOndon
    • London, Greater LOndon, United Kingdom, W21Y
      • St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older Subjects expected to undergo catheterisation as part of their clinical care. Signed informed consent is a prerequisite for inclusion in the study.

Exclusion Criteria:

• Consent to participate not given Known sensitivity to urinary catheters or electronic products Patients undergoing urologic procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; A single arm will have biosensor (experimental) diagnoses compared to clinical (control, current standard of care). All participants in this group willl have a biosensor, with the data masked to patients, providers and clinical researchers	Diagnostic test: Smart Catheter Biosensor; A novel biosensor in-built into the catheter drainage system that monitors the chemical composition of the urine, with the intention of providing early diagnosis of developing infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time difference of diagnosis	The time difference of biosensor diagnosis of catheter associated UTI as compared to clinical diagnosis (defined as the prescription time of new antimicrobials for suspected UTI)	From the time of catheterisation, until 72hours post-removal of catheters.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	The proportion of those subjects who went on to develop CAUTI did the Smart Catheter correctly predict would have CAUTI?	From the time of catheterisation, until 72hours post-removal of catheters.
Specificity	The proportion of those subjects who did not go on to develop CAUTI did the Smart Catheter correctly predict would not have CAUTI.	From the time of catheterisation, until 72hours post-removal of catheters.
False Positive Rate	The proportion of those subjects who would not go on to have CAUTI did the Smart Catheter incorrectly predict would have CAUTI?	From the time of catheterisation, until 72hours post-removal of catheters.
False Negative Rate	The proportion of those subjects who would go on to have CAUTI did the Smart Catheter incorrectly predict would not have CAUTI?	From the time of catheterisation, until 72hours post-removal of catheters.

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Biosensor
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: 17SM4299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Participant Data is confidential and will to be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No