Urinary Tract Infections
Conditions
Keywords
Overactive Bladder, PCR, Urine Culture, Botox Injection
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.
Interventions
DIAGNOSTIC_TESTMultiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)
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.
DIAGNOSTIC_TESTUrine Culture
A traditional clinical UTI evaluation consisting of non-molecular standard urine culture (SUC) and sensitivity testing methods.
Sponsors
Pathnostics
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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.) |
| 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 |
| Resistant UTI | Up to 12 months post-injection | Defined as UTI that manifests as a persistence or worsening of symptoms during antibiotic course |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed