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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Özgür Aslan, MD
- 전화번호: +90 5384243325
- 이메일: ozgraslan92@gmail.com
연구 장소
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Bagcilar
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Istanbul, Bagcilar, 터키 (Türkiye), 34200
- Bagcilar Training and Research Hospital
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연락하다:
- Özgür Aslan, MD
- 전화번호: +90 5384243325
- 이메일: ozgraslan92@gmail.com
-
수석 연구원:
- Özgür Aslan, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response
기간: 3 months
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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.
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Discriminative ability of baseline platelet-to-lymphocyte ratio for mirabegron treatment response
기간: 3 months
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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.
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3 months
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Discriminative ability of baseline systemic immune-inflammation index for mirabegron treatment response
기간: 3 months
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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.
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3 months
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Association of baseline NLR with mirabegron treatment response adjusted for clinical covariates
기간: 3 months
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The adjusted odds ratio and 95 percent confidence interval for baseline NLR are estimated with composite treatment response as the dependent variable.
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Özgür Aslan, MD, Bagcilar Training and Research Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- BagcilarTRH-OBSGYN-937
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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