Clinical trial NCT04817865: Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox Injection
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Urinary Tract Infections
Keywords: Overactive Bladder
PCR
Urine Culture
Botox Injection
Lead sponsor: Pathnostics
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving Botox injections for the treatment of neurogenic or non-neurogenic OAB

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.

Eligibility 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

Primary outcomes:
measure: Post procedural UTI
timeFrame: Up to 3 weeks post injection
measure: Recurrent UTI
timeFrame: Up to 12 months post-injection
measure: Resistant UTI
timeFrame: Up to 12 months post-injection
measure: Antibiotic Usage
timeFrame: Up to 3 weeks post-injection
measure: Visit Reschedule/Cancellation Rate
timeFrame: Up to 1 year after pre-procedural assessment
Secondary outcomes:
measure: UTI-related ED Visit Rate
timeFrame: Up to 3 weeks post-injection
measure: UTI-hospital Admission Rate
timeFrame: Up to 3 weeks post-injection
Other outcomes:
Locations:
city: Barrington
country: United States
facility: Comprehensive Urologic Care
state: Illinois
Study officials:
affiliation: Pathnostics, Inc.
name: David Baunoch, PhD
role: PRINCIPAL_INVESTIGATOR
References: