Overactive Bladder (OAB)NCT07773532
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
An observational study of Overactive Bladder (OAB), run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Mirabegron (beta3-adrenoceptor agonist)
- Type of treatment
- Pill or oral medicine
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2026to 2 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bagcilar Training and Research Hospital
Istanbul, Bagcilar, 34200
Özgür Aslan, MD, +90 5384243325, ozgraslan92@gmail.com
Özgür Aslan, MD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Mirabegron (beta3-adrenoceptor agonist)
- 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
- Medical subject headings
- Urinary Bladder, Overactive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 ICIQ-UI SF questionnaire, routine urodynamic evaluation, and a standardized complete blood count; treatment response and global improvement are assessed at 3 months using the ICIQ-UI SF and PGI-I scales. Receives: Drug: Mirabegron (beta3-adrenoceptor agonist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start2 Nov 2026
- Primary completion2 Nov 2027 (estimated)
- Study completion2 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, özgür aslan, Bagcilar Training and Research Hospital
- Investigators
- Özgür Aslan, MD, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773532
- Sponsor's protocol ID
- BagcilarTRH-OBSGYN-937
- Status last verified
- Nov 2026
- First submitted
- 15 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38461853Matta 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.
PubMed 37120417Zheng 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.
PubMed 40333820Kim 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.
PubMed 34711592
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07773532
- Acronym / sponsor ID
- BagcilarTRH-OBSGYN-937
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 2 Nov 2026 (actual)
- Primary completion
- 2 Nov 2027 (estimated)
- Study completion
- 2 Nov 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-naive OAB cohort | – | Drug: Mirabegron (beta3-adrenoceptor agonist)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 ICIQ-UI SF questionnaire, routine urodynamic evaluation, and a standardized complete blood count; treatment response and global improvement are assessed at 3 months using the ICIQ-UI SF and PGI-I scales. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment-naive OAB cohort |
Primary outcome
Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response
Time frame: 3 months
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.
3 secondary outcomes
Discriminative ability of baseline platelet-to-lymphocyte ratio for mirabegron treatment response
Time frame: 3 months
Discriminative ability of baseline systemic immune-inflammation index for mirabegron treatment response
Time frame: 3 months
Association of baseline NLR with mirabegron treatment response adjusted for clinical covariates
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 38461853Kwon 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.
- Background: PubMed 37120417Matta 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.
- Background: PubMed 40333820Zheng 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.
- Background: PubMed 34711592Kim 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Özgür Aslan, MD principal investigator
Bagcilar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder (OAB), run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özgür Aslan, MD (+90 5384243325, ozgraslan92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discriminative ability of baseline neutrophil-to-lymphocyte ratio for mirabegron treatment response (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07773532, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.