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Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder

2026年8月18日 更新者：özgür aslan、Bagcilar Training and Research Hospital

Predictive Capacity of Baseline Neutrophil-to-Lymphocyte Ratio, Platelet-to-Lymphocyte Ratio, and Systemic Immune-Inflammation Index for Mirabegron Treatment Response in Women With Overactive Bladder: A Prospective Cohort Study

Overactive bladder (OAB) is associated with systemic chronic inflammation. Indices derived from complete blood count (such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII)) have shown associations with OAB presence. However, whether baseline inflammatory status predicts response to beta-3 adrenergic agonist therapy remains untested. This prospective observational cohort study evaluates the predictive ability of baseline NLR, PLR, and SII for 3-month treatment response to mirabegron 50 mg in women with OAB.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

BACKGROUND AND RATIONALE: Overactive bladder (OAB) is a chronic lower urinary tract condition characterized by urinary urgency, usually accompanied by frequency and nocturia, with or without urgency incontinence. Beta-3 adrenoceptor agonists such as mirabegron are an established first-line pharmacological option, yet the individual treatment response varies considerably. Emerging evidence links systemic low-grade inflammation to OAB pathophysiology. Baseline hematological indices derived from the routine complete blood count, such as the neutrophil-to-lymphocyte ratio (NLR), the platelet-to-lymphocyte ratio (PLR), and the systemic immune-inflammation index (SII), may therefore carry predictive information at no additional cost.

STUDY OBJECTIVES: This prospective observational cohort study evaluates whether baseline NLR predicts the clinical response to standard mirabegron therapy (50 mg/day) at 3 months in treatment-naive women with OAB. The discriminative ability of baseline PLR and SII and the adjusted association of NLR with response are evaluated as secondary objectives.

METHODS: Consecutive eligible treatment-naive women in whom mirabegron 50 mg is initiated within routine clinical care are enrolled. Baseline evaluation includes clinical assessment, a 3-day voiding diary, a validated symptom questionnaire, routine urodynamic parameters, and a standardized complete blood count. Inflammatory indices are calculated with standard formulas. Response is assessed at 3 months. Data are collected on standardized case report forms and verified against electronic medical records.

STATISTICAL CONSIDERATIONS: The enrollment target is 115 patients to reach 80 evaluable patients. The discriminative ability of baseline inflammatory indices will be evaluated with ROC curve analysis; multivariable modeling will be used to assess adjusted associations. Details are prespecified in the study protocol.

研究类型

观察性的

注册 (估计的)

115

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 土耳其（türkiye）
    • Bagcilar
      • Istanbul、Bagcilar、土耳其（türkiye）、34200
        • Bagcilar Training and Research Hospital
        • 接触：
        • 首席研究员：
          • Özgür Aslan, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Treatment-naive adult women with overactive bladder attending the urogynecology outpatient clinic of a tertiary referral hospital in Istanbul, Turkey, in whom mirabegron 50 mg is initiated within routine clinical care. Consecutive eligible patients are enrolled.

描述

Inclusion Criteria:

  • Female patients aged 18 years or older
  • Overactive bladder symptoms for at least 3 months
  • Mirabegron 50 mg planned by physician decision within routine care
  • Ability to provide written informed consent

Exclusion Criteria:

  • Any previous OAB-specific treatment other than behavioral therapy (oral antimuscarinic or beta-3 agonist, intravesical botulinum toxin, sacral neuromodulation, or posterior tibial nerve stimulation)
  • Acute infection within the last 4 weeks, including culture-confirmed urinary tract infection
  • Chronic inflammatory disease (rheumatologic or autoimmune disease, or inflammatory bowel disease)
  • Active malignancy or cancer treatment within the last 5 years
  • Use of systemic glucocorticoids within the last 4 weeks, or chronic NSAID or immunosuppressive use
  • Conditions affecting lower urinary tract function other than OAB (neurogenic bladder, urinary tract stones, history of pelvic radiotherapy or bladder surgery, pelvic organ prolapse stage 3 or higher, or stress-predominant mixed urinary incontinence)
  • Known diagnosis of hematologic disease, anemia (Hb<9), or platelet disorder (PLT<100.000 or >600.000)
  • Significant renal or hepatic impairment (eGFR below 30 mL/min/1.73 m2, or Child-Pugh class B or C)
  • Uncontrolled hypertension (180/110 mmHg or higher) or any other contraindication to mirabegron
  • Pregnancy or lactation
  • Major surgery or trauma within the last 3 months
  • Cognitive or functional inability to complete the voiding diary

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Treatment-naive OAB cohort
Treatment-naive adult women with overactive bladder in whom mirabegron 50 mg once daily is initiated by physician decision within routine clinical care. Baseline assessment includes a 3-day voiding diary, the OAB-q short form, routine urodynamic evaluation, and a standardized complete blood count; treatment response is assessed at 3 months.
药品：Mirabegron (beta3-adrenoceptor agonist)
Mirabegron 50 mg orally once daily, initiated and managed by the treating physician as part of routine clinical care. The drug is not assigned by the study protocol; the study observes patients in whom this treatment has been started within standard practice.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response
大体时间：3 months
Treatment response is defined as a composite of a reduction of at least 50 percent from baseline in the symptom severity score of the Overactive Bladder Questionnaire Short Form (OAB-q SF) AND a reduction of at least 2 in the mean number of daily urgency episodes on a 3-day voiding diary; both conditions are required. The OAB-q SF symptom severity score is transformed to a 0 to 100 scale, with higher scores indicating greater symptom severity; a decrease therefore represents improvement. The area under the ROC curve (AUC) of baseline neutrophil-to-lymphocyte ratio for discriminating responders from non-responders is reported with its 95 percent confidence interval.
3 months

次要结果测量

结果测量
措施说明
大体时间
Discriminative ability of baseline platelet-to-lymphocyte ratio for mirabegron treatment response
大体时间：3 months
The area under the ROC curve of baseline PLR for discriminating responders from non-responders (composite response definition) is reported with its 95 percent confidence interval.
3 months
Discriminative ability of baseline systemic immune-inflammation index for mirabegron treatment response
大体时间：3 months
The area under the ROC curve of baseline SII for discriminating responders from non-responders (composite response definition) is reported with its 95 percent confidence interval.
3 months
Association of baseline NLR with mirabegron treatment response adjusted for clinical covariates
大体时间：3 months
The adjusted odds ratio and 95 percent confidence interval for baseline NLR are estimated with composite treatment response as the dependent variable.
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bagcilar Training and Research Hospital

调查人员

  • 首席研究员：Özgür Aslan, MD、Bagcilar Training and Research Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2026年8月15日

首先提交符合 QC 标准的

2026年8月18日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月18日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BagcilarTRH-OBSGYN-937

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared in order to protect participant privacy and maintain compliance with institutional data protection regulations. De-identified aggregate data that support the findings of this study will be available upon reasonable request from the corresponding author.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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