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
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
- 是
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)
