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Overactive Bladder (OAB)Phase 4BEAMNCT07711808

Burden and Efficacy of Anticholinergic vs Mirabegron in Overactive Bladder - A Randomized Controlled Study

A Phase 4 study testing Solifencin and Mirabegron in people with Overactive Bladder (OAB), run by Universidade do Porto.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Overactive bladder (OAB) is a common condition that causes a sudden, strong need to urinate, often with frequent daytime and night-time trips to the toilet, and sometimes leaking. It can have a substantial impact on everyday quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder (OAB)
What is being tested?
Solifencin and Mirabegron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
No sites listed yet
Study dates
Jul 2026to Aug 2027
Phase
Phase 4
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients with a clinical diagnosis of overactive bladder syndrome.
  • Treatment-naïve for OAB pharmacotherapy (no prior antimuscarinic or mirabegron for OAB).
  • Able to complete the ICIQ-OAB questionnaire and a frequency-volume chart.
  • Written informed consent.

Who cannot join

  • Neurogenic bladder.
  • Previous treatment with anticholinergics or mirabegron for OAB.
  • History of pelvic radiotherapy or bladder cancer.
  • Post-void residual volume > 200 mL.
  • Clinically significant stress urinary incontinence.
  • Chronic pelvic pain syndrome.
Show all 10Show fewer
  • Congenital urinary tract malformations.
  • Prior bladder surgery; history of mid-urethral sling or prostate surgery.
  • Contraindication to solifenacin or mirabegron.
  • End-stage renal disease on dialysis.

About this study

Official title: BURDEN AND EFFICACY OF ANTICHOLINERGIC VS MIRABEGRON IN OVERACTIVE BLADDER - A RANDOMIZED CONTROLLED STUDY

Overactive bladder (OAB) is a common condition that causes a sudden, strong need to urinate, often with frequent daytime and night-time trips to the toilet, and sometimes leaking. It can have a substantial impact on everyday quality of life. Two of the most common medicines used to treat OAB work in different ways: one type (antimuscarinics, such as solifenacin) blocks a nerve signal in the bladder, while another type (beta-3 agonists, such as mirabegron) helps the bladder muscle relax.

Many people with OAB are already taking other medicines - for example, for mood, sleep, or allergies - that, without being intended for the bladder, also block that same nerve signal. The combined effect of all these medicines is called the "anticholinergic burden." Researchers want to understand whether a person's existing anticholinergic burden changes how well each OAB treatment works. The idea is that if this nerve pathway is already heavily blocked by other medicines, an antimuscarinic might be less helpful, and a treatment that works in a different way (mirabegron) might be a better choice.

In this study, adults with newly diagnosed OAB who have not yet been treated will be randomly assigned to take either solifenacin or mirabegron once a day. Before starting, each participant's anticholinergic burden will be measured using a validated tool called the Drug Burden Index (DBI) and ACB. Bladder symptoms will be assessed with a standard questionnaire (ICIQ-FLUTS) and a bladder diary at the start of treatment and again after 1 and 2 months. By comparing how participants respond depending on their baseline anticholinergic burden, the study aims to learn whether measuring this burden can help doctors choose the most effective first-line treatment for each patient.

Being tested
Solifencin, Mirabegron
Keywords
Overactive bladder, Anticholinergic burden
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SolifencinDrug

    Patients will receive solifenacin succinate 5 mg, an oral selective M3 antimuscarinic, taken once daily for 2 months. Solifenacin reduces overactive bladder symptoms by blocking muscarinic receptor-mediated detrusor contractions.

  • MirabegronDrug

    Participants randomized to this arm receive mirabegron 50 mg, an oral β3-adrenergic agonist, taken once daily for 2 months. Mirabegron relieves overactive bladder symptoms through a non-anticholinergic mechanism, promoting detrusor relaxation during the storage phase.

Study groups in NCT07711808
Study groupRoleWhat they receive
Low Anticholinergic Burden - SolifenacinExperimentalParticipants randomized to this arm receive solifenacin succinate 5 mg, an oral selective M3 antimuscarinic, taken once daily for 2 months. Solifenacin reduces overactive bladder symptoms by blocking muscarinic receptor-mediated detrusor contractions.
Receives: Drug: Solifencin
Low Anticholinergic Burden - MirabegronActive comparatorParticipants randomized to this arm receive mirabegron 50 mg, an oral β3-adrenergic agonist, taken once daily for 2 months. Mirabegron relieves overactive bladder symptoms through a non-anticholinergic mechanism, promoting detrusor relaxation during the storage phase.
Receives: Drug: Mirabegron
High Anticholinergic Burden - MirabegronActive comparatorParticipants randomized to this arm receive mirabegron 50 mg, an oral β3-adrenergic agonist, taken once daily for 2 months. Mirabegron relieves overactive bladder symptoms through a non-anticholinergic mechanism, promoting detrusor relaxation during the storage phase.
Receives: Drug: Mirabegron
High Anticholinergic Burden - SolifenacinExperimentalParticipants randomized to this arm receive solifenacin succinate 5 mg, an oral selective M3 antimuscarinic, taken once daily for 2 months. Solifenacin reduces overactive bladder symptoms by blocking muscarinic receptor-mediated detrusor contractions.
Receives: Drug: Solifencin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICIQ OAB

    This measure captures how much overactive bladder symptoms change after two months of treatment. The ICIQ-OAB (International Consultation on Incontinence Questionnaire - Overactive Bladder) is a validated, patient-completed questionnaire covering the core symptoms of the condition: daytime urinary frequency, night-time urination (nocturia), urgency, and urgency-related leakage. The four symptom items are summed into a total score ranging from 0 to 16, where a higher score means more severe symptoms. Participants complete the questionnaire at the start of treatment (baseline) and again at 2 months; the outcome is the change between these two time points, with a larger reduction indicating greater symptom improvement. The two treatment arms are compared using an analysis of covariance (ANCOVA) adjusted for each participant's baseline score, performed separately within the high anticholinergic burden group (Drug Burden Index ≥ 1) and the low burden group (DBI < 1).

    Measured: From enrollment to 4 and 8 weeks

Secondary outcomes (4)

  1. Responder rate at Month 2

    This measure reports the proportion of participants who achieve a clinically meaningful improvement in symptoms. A participant is classified as a "responder" if their ICIQ-OAB total score falls by at least 3 points from baseline to 2 months - a reduction generally regarded as noticeable and worthwhile to patients. The outcome is the percentage of responders in each treatment arm.

    Measured: From enrollment to 8 weeks

  2. Change in frequency-volume chart parameters at Month 2

    A frequency-volume chart (bladder diary) is a record that participants keep at home, noting the time and volume of each urination over a defined period. From this diary, three parameters are measured at baseline and at 2 months, and the change between them is reported: (1) the number of urinations per 24 hours; (2) the number of night-time urination episodes (nocturia); and (3) the average volume passed per urination (in millilitres). Fewer urinations and fewer nocturia episodes, together with a larger average voided volume, indicate symptom improvement.

    Measured: From enrollment to 8 weeks

  3. Treatment discontinuation rate

    This measure reports the proportion of participants in each arm who stop their assigned treatment before completing the 2-month study period, for any reason (for example, side effects, lack of benefit, or personal choice). It is expressed as a percentage of participants randomized to that arm and serves as an indicator of how well each treatment is tolerated and accepted in practice.

    Measured: From enrollment to the end of 8 weeks

  4. Incidence of adverse events

    This measure records the number and type of adverse events - any unwanted or harmful medical occurrence reported by participants or observed by the study team - during treatment. Adverse events are collected at each follow-up visit through 2 months and summarized by arm, including the proportion of participants experiencing at least one event. This outcome describes the safety and tolerability profile of each treatment.

    Measured: From enrollment to the end of 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07711808
Sponsor's protocol ID
BEAM
Acronym
BEAM
Status last verified
Jun 2026
First submitted
13 Jul 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Solifencin and Mirabegron in people with Overactive Bladder (OAB), run by Universidade do Porto.

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 10 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: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICIQ OAB (time frame: From enrollment to 4 and 8 weeks). 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 NCT07711808.

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 17 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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