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

NCT04817865 | Withdrawn

• 1 other identifier: 2020-btxuti
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Tract Infections

Keywords

Overactive Bladder; PCR; Urine Culture; Botox Injection

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• UTI-related ED Visit Rate

  Up to 3 weeks post-injection

• UTI-hospital Admission Rate

  Up to 3 weeks post-injection

Study Arms (2)

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

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)

Interventions

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

Pre-Procedural M-PCR/P-AST

Urine Culture DIAGNOSTIC_TEST

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

Standard Pre-Procedural Urine Culture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pathnostics: lead

Study Sites (1)

Comprehensive Urologic Care

Barrington, Illinois, 60010, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Baunoch, PhD

  Pathnostics, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: August 15, 2020
• Primary Completion: February 10, 2021
• Study Completion: July 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)