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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Retrospective Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox for the Treatment of Neurogenic or Non-neurogenic Overactive Bladder

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Diagnostic Test: Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)
* Diagnostic Test: Urine Culture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Pre-Procedural Urine Culture<br>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. | Diagnostic Test: Urine Culture<br>* A traditional clinical UTI evaluation consisting of non-molecular standard urine culture (SUC) and sensitivity testing methods.<br>|
| Pre-Procedural M-PCR/P-AST<br>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. | Diagnostic Test: Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)<br>* M-PCR/P-AST is a dual assessment test that detects pathogenic DNA commonly associated with urinary tract infections and identifies their genotypic and phenotypic antibiotic resistance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post procedural UTI | Defined as development of UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy | Up to 3 weeks post injection | 
| Recurrent UTI | Defined as the development of multiple UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy | Up to 12 months post-injection | 
| Resistant UTI | Defined as UTI that manifests as a persistence or worsening of symptoms during antibiotic course | Up to 12 months post-injection | 
| Antibiotic Usage | Defined as total number of post-procedural antibiotics ordered/taken within 3 weeks post BOTOX injection | Up to 3 weeks post-injection | 
| Visit Reschedule/Cancellation Rate | Defined as any injection visit cancelled/postponed/rescheduled due to results of preprocedural assessments (abnormal UA, lower urinary tract symptoms etc.) | Up to 1 year after pre-procedural assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTI-related ED Visit Rate | Defined as any visit to the ED relating to symptoms of UTI within 3 weeks post-Botox injection | Up to 3 weeks post-injection | 
| UTI-hospital Admission Rate | Defined as any admission to the hospital (from home/ED or clinic transfer) relating to symptoms of UTI within 3 weeks post-Botox injection | Up to 3 weeks post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, PCR, Urine Culture, Botox Injection