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

NCT07773532 | Not Yet Recruiting

• 1 other identifier: BagcilarTRH-OBSGYN-937
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder (OAB)

Keywords

Overactive Bladder; Adrenergic beta 3 Receptor Agonists; Inflammation; Biomarkers; Blood Cell Counts; Neutrophil-to-Lymphocyte Ratio; Platelet-to-Lymphocyte Ratio; Systemic Immune-Inflammation Index; NLR; PLR; SII

Outcome Measures

Primary Outcomes (1)

• Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response

  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

Secondary Outcomes (3)

• Discriminative ability of baseline platelet-to-lymphocyte ratio for mirabegron treatment response

  3 months

• Discriminative ability of baseline systemic immune-inflammation index for mirabegron treatment response

  3 months

• Association of baseline NLR with mirabegron treatment response adjusted for clinical covariates

  3 months

Study Arms (1)

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.

Drug: Mirabegron (beta3-adrenoceptor agonist)

Interventions

Mirabegron (beta3-adrenoceptor agonist) DRUG

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.

Treatment-naive OAB cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, Bagcilar, 34200, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 38461853 BACKGROUND

• 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.

  PMID: 37120417 BACKGROUND

• 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.

  PMID: 40333820 BACKGROUND

• 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.

  PMID: 34711592 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Inflammation

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Özgür Aslan, MD

  Bagcilar Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özgür Aslan, MD

CONTACT

+90 5384243325; ozgraslan92@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 19, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)