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临床试验/NCT04817865
NCT04817865撤回不适用

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

Pathnostics1 个研究点 分布在 1 个国家开始时间: 2020年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Pathnostics
试验地点
1
主要终点
Resistant UTI

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

结局指标

主要结局

Resistant UTI

时间窗: Up to 12 months post-injection

Defined as UTI that manifests as a persistence or worsening of symptoms during antibiotic course

Antibiotic Usage

时间窗: Up to 3 weeks post-injection

Defined as total number of post-procedural antibiotics ordered/taken within 3 weeks post BOTOX injection

Visit Reschedule/Cancellation Rate

时间窗: Up to 1 year after pre-procedural assessment

Defined as any injection visit cancelled/postponed/rescheduled due to results of preprocedural assessments (abnormal UA, lower urinary tract symptoms etc.)

Recurrent UTI

时间窗: Up to 12 months post-injection

Defined as the development of multiple UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy

Post procedural UTI

时间窗: Up to 3 weeks post injection

Defined as development of UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy

次要结局

  • UTI-related ED Visit Rate(Up to 3 weeks post-injection)
  • UTI-hospital Admission Rate(Up to 3 weeks post-injection)

研究者

发起方
Pathnostics
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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