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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Diagnostic test: Urine Culture; Diagnostic test: Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Barrington, Illinois, United States, 60010
      • Comprehensive Urologic Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving Botox injections for the treatment of neurogenic or non-neurogenic OAB

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Pre-Procedural 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.	Diagnostic test: Urine Culture; A traditional clinical UTI evaluation consisting of non-molecular standard urine culture (SUC) and sensitivity testing methods.
Pre-Procedural 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.	Diagnostic test: Multiplex-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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pathnostics
• Investigators: Principal Investigator: David Baunoch, PhD, Pathnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Overactive Bladder; PCR; Botox Injection; Urine Culture
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2020-btxuti

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No