Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Özgür Aslan, MD
- 電話番号：+90 5384243325
- メール：ozgraslan92@gmail.com
研究場所
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Bagcilar
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Istanbul、Bagcilar、トルコ（Türkiye）、34200
- 募集
- Bagcilar Training and Research Hospital
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コンタクト：
- Özgür Aslan, MD
- 電話番号：+90 5384243325
- メール：ozgraslan92@gmail.com
-
主任研究者：
- Özgür Aslan, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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 ICIQ-UI SF questionnaire, routine urodynamic evaluation, and a standardized complete blood count; treatment response and global improvement are assessed at 3 months using the ICIQ-UI SF and PGI-I scales. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response
時間枠：3 months
|
Treatment response is defined as achieving a minimally clinically important difference (MCID) of a reduction of at least 3 points from baseline in the total International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) score at 3 months, cross-validated by patient-reported improvement on the Patient Global Impression of Improvement (PGI-I) scale (ratings of "very much improved" or "much improved"). The total ICIQ-UI SF score ranges from 0 to 21, with higher scores indicating greater symptom severity and impact on quality of life; a decrease represents clinical 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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Discriminative ability of baseline platelet-to-lymphocyte ratio for mirabegron treatment response
時間枠：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
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Discriminative ability of baseline systemic immune-inflammation index for mirabegron treatment response
時間枠：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
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Association of baseline NLR with mirabegron treatment response adjusted for clinical covariates
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Özgür Aslan, MD、Bagcilar Training and Research Hospital
出版物と役立つリンク
一般刊行物
- Kwon J, Kim DY, Cho KJ, Hashimoto M, Matsuoka K, Kamijo T, Wang Z, Karnup S, Robertson AM, Tyagi P, Yoshimura N. Pathophysiology of Overactive Bladder and Pharmacologic Treatments Including beta3-Adrenoceptor Agonists -Basic Research Perspectives. Int Neurourol J. 2024 Feb;28(Suppl 1):12-33. doi: 10.5213/inj.2448002.001. Epub 2024 Feb 29.
- Matta R, Saskin R, Neu S, Locke JA, Kowalczyk A, Steup A, Herschorn S. Predicting Mirabegron Treatment Response in Patients with Overactive Bladder: A Post Hoc Analysis of Data from Clinical Trials. Eur Urol Focus. 2023 Nov;9(6):957-965. doi: 10.1016/j.euf.2023.04.001. Epub 2023 Apr 27.
- Zheng P, Wang X, Ni J. Relationship between the systemic immune-inflammatory index and overactive bladder risk: A cross-sectional assessment involving United States Adults. PLoS One. 2025 May 7;20(5):e0323052. doi: 10.1371/journal.pone.0323052. eCollection 2025.
- Kim S, Park JH, Oh YH, Kim HJ, Kong MH, Moon J. Correlation between neutrophil to lymphocyte ratio and overactive bladder in South Korean women: a community-based, cross-sectional study. BMJ Open. 2021 Oct 28;11(10):e048309. doi: 10.1136/bmjopen-2020-048309.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BagcilarTRH-OBSGYN-937
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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