Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox Injection

Pathnostics

Status: Withdrawn

Conditions: Urinary Tract Infections

Treatments: Diagnostic Test: Urine Culture; Diagnostic Test: Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)

Study type: Observational

Funder types: Industry

Identifiers

NCT04817865

2020-btxuti

Details and patient eligibility

About

This study is a retrospective record review to determine whether a novel multiplex PCR assay can be utilized as a screening method for UTI in patients receiving Botox injection to treat overactive bladder (OAB).

Full description

The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by a previous prospective comparison study. This is a retrospective record review comparing PCR and culture-based assessments for UTI in patients receiving Botox injection to treat overactive bladder (OAB). Investigators aim to determine whether M-PCR/P-AST can be utilized as a screening method for UTI in these patients and whether whether antibiotic prophylaxis, peri-procedural antibiotics, and post-injection antibiotic therapy based on patients' pre-procedural M-PCR/P-AST results in improved response to Botox injection compared to standard of care. The attributes and advantages of PCR testing over the use of traditional urine cultures, and the potential identification of polymicrobial infections with complicated resistance sharing mechanisms, may significantly improve patient care.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion/Exclusion Criteria:

• Subject is male or female
• >18 years of age at date of injection
• Subject receiving BoNT injection for symptoms of OAB (including urgency, urinary incontinence, and detrusor overactivity) refractory to first-line therapies

Trial design

0 participants in 2 patient groups

Standard Pre-Procedural Urine Culture

Description:

This is a control cohort that follows standard pre-procedural protocol by implementing antibiotic prophylaxis and treatment regimens based on dipstick urine analysis (UA) followed by reflexed traditional urine culture and sensitivity (C\&S) methods performed before injection.

Treatment:

Diagnostic Test: Urine Culture

Pre-Procedural M-PCR/P-AST

Description:

This is an experimental cohort that implements Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST) for pre-procedural UTI screening. The cohort follows an antibiotic treatment regimen based on the results of M-PCR/P-AST.

Treatment:

Diagnostic Test: Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)