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.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response — 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.
Trial sites (1)
Facility
City
Region
Status
Bagcilar Training and Research Hospital
Istanbul
Bagcilar
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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