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

18 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

115

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Turkiet (Türkiye)
    • Bagcilar
      • Istanbul, Bagcilar, Turkiet (Türkiye), 34200
        • Bagcilar Training and Research Hospital
        • Kontakt:
        • Huvudutredare:
          • Özgür Aslan, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Discriminative ability of baseline platelet-to-lymphocyte ratio for mirabegron treatment response
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bagcilar Training and Research Hospital

Utredare

  • Huvudutredare: Özgür Aslan, MD, Bagcilar Training and Research Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 oktober 2027

Avslutad studie (Beräknad)

1 november 2027

Studieregistreringsdatum

Först inskickad

15 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

18 augusti 2026

Första postat (Faktisk)

19 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • BagcilarTRH-OBSGYN-937

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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