Predictive value of inflammatory biomarkers for mirabegron response in women with overactive bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study follows treatment-naive women with overactive bladder who start mirabegron 50 mg in routine care. Baseline inflammatory indices from a standard blood count, including NLR, PLR, and SII, are calculated to see if they predict a 3-month treatment response. Researchers will assess response using clinical data, a voiding diary, and symptom questionnaires, with additional exploration of how PLR and SII relate to outcomes. The aim is to determine whether inexpensive blood tests can help forecast who benefits from beta-3 agonist therapy. Results could inform personalized planning for OAB management.

Why it matters

Who can join: the full rules

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

Where it's running

• Bagcilar Training and Research Hospital
  Istanbul, Bagcilar, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Özgür Aslan, MD — Bagcilar Training and Research Hospital
• Study coordinator: Özgür Aslan, MD
• Email: ozgraslan92@gmail.com
• Phone: +90 5384243325

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.