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

Urinary Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04817865
• Other study ID #: 2020-btxuti
• Status: Withdrawn
• Start date: August 15, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: November 2023
• Source: Pathnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2023
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Comprehensive Urologic Care	Barrington	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pathnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Resistant UTI	Defined as UTI that manifests as a persistence or worsening of symptoms during antibiotic course	Up to 12 months post-injection
Primary	Antibiotic Usage	Defined as total number of post-procedural antibiotics ordered/taken within 3 weeks post BOTOX injection	Up to 3 weeks post-injection
Primary	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	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
Secondary	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