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

NCT ID: NCT04817865

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-15
• Study Completion Date: 2023-07-31

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.

Conditions

Urinary Tract Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Urine Culture

Intervention Type: DIAGNOSTIC_TEST

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.

Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Urine Culture

A traditional clinical UTI evaluation consisting of non-molecular standard urine culture (SUC) and sensitivity testing methods.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pathnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Baunoch, PhD

Role: PRINCIPAL_INVESTIGATOR

Pathnostics, Inc.

Locations

Comprehensive Urologic Care

Barrington, Illinois, United States

Countries

United States

Other Identifiers

2020-btxuti

Identifier Type: -

Identifier Source: org_study_id