3PU: Development of a novel diagnostic tool aimed at prediction, prognosis and prevention of urinary tract infections (UTIs) in spinal cord injury people who use catheters for bladder management

Not Applicable

Recruiting

• Conditions: catheter associated UTI; Infection - Studies of infection and infectious agents; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12622000613707
• Lead Sponsor: niversity of Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-26
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Adults, age 18 years and older;
2.Had a known neurogenic bladder;
3.Had a stable SCI or stable multiple sclerosis with a known spinal demyelinating lesion;
4.Had a stable bladder management technique [i.e. not expected to change their bladder management technique, and having performed their (stable) bladder management technique for at least 4 weeks] and using a bladder management technique such as indwelling catheter, suprapubic catheter, clean intermittent self-catheterisation or reflex/condom drainage;
5.Agreed to fortnightly telephone consultation for themselves and their care team during the eighteen month study period;
6.Agreed that the microbial community and the microbiome DNA from the catheter and urine samples you provide to be extracted and stored long-term.

Exclusion Criteria

1.Expected to change their bladder management technique or changed bladder management technique for less than at least 4 weeks
2.External condom drainage (ECD) is the only type of catheter used (ECD alongside intermittent catheter (IMC) is allowed)
3.Being treated for, or symptomatic from a current infection or longstanding pressure sore;
4.Known to have a complex bladder disturbance requiring surgical intervention e.g. known cystoplasty, renal or bladder calculus, significant hydronephrosis, or current pyelonephritis;
5.Known to have chronic open wound/s or known longstanding osteomyelitis [greater than 6 weeks];
6.On long-term antibiotic therapy for any indication;
7.Known to have severe renal or hepatic failure;
8.Requiring full [invasive] mechanical ventilation;
9.Receiving immunosuppressant medications or have an underlying immunosuppressive disease [for example HIV or endstage/Progressive diabetes mellitus, multiple sclerosis or cerebrovascular disease];
10.Concurrently enrolled in an intervention study which involves probiotics, bladder instrumentation, antibiotics of any sort or involving medications which would suppress the immune system; (observational studies or inclusion following completion of another study is allowed).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of shift in each participants microbiome during UTI event compared to the non symptomatic period using microbial community analysis (metagenome sequencing) of the entire bacterial community of biofilm in used catheter and fresh catch urine samples [ Cumulative data will be assessed at the conclusion of the study]

Secondary Outcome Measures

Name	Time	Method
Assessment of personal health and utility EQ-5D-5L on asymptomatic catheter change and in the event of UTIs[ Cumulative data will be assessed at the conclusion of the study]