Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox Injection
- Conditions
- Urinary Tract Infections
- Interventions
- Diagnostic Test: Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)Diagnostic Test: Urine Culture
- Registration Number
- NCT04817865
- Lead Sponsor
- Pathnostics
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pre-Procedural M-PCR/P-AST Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST) 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. Standard Pre-Procedural Urine Culture Urine Culture 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.
- Primary Outcome Measures
Name Time Method Resistant UTI Up to 12 months post-injection Defined as UTI that manifests as a persistence or worsening of symptoms during antibiotic course
Antibiotic Usage Up to 3 weeks post-injection Defined as total number of post-procedural antibiotics ordered/taken within 3 weeks post BOTOX injection
Visit Reschedule/Cancellation Rate Up to 1 year after pre-procedural assessment Defined as any injection visit cancelled/postponed/rescheduled due to results of preprocedural assessments (abnormal UA, lower urinary tract symptoms etc.)
Recurrent UTI Up to 12 months post-injection Defined as the development of multiple UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy
Post procedural UTI Up to 3 weeks post injection Defined as development of UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy
- Secondary Outcome Measures
Name Time Method UTI-related ED Visit Rate Up to 3 weeks post-injection Defined as any visit to the ED relating to symptoms of UTI within 3 weeks post-Botox injection
UTI-hospital Admission Rate Up to 3 weeks post-injection Defined as any admission to the hospital (from home/ED or clinic transfer) relating to symptoms of UTI within 3 weeks post-Botox injection
Trial Locations
- Locations (1)
Comprehensive Urologic Care
🇺🇸Barrington, Illinois, United States