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.
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
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
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.
Cohort
Prospective
Mirabegron (beta3-adrenoceptor agonist)
DrugMirabegron 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.
Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response
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.
Discriminative ability of baseline platelet-to-lymphocyte ratio for mirabegron treatment response
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.
Discriminative ability of baseline systemic immune-inflammation index for mirabegron treatment response
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.
Association of baseline NLR with mirabegron treatment response adjusted for clinical covariates
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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