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

NCT07711808 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-07-17

No results posted yet for this study

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. 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.

Conditions

  • Overactive Bladder (OAB)

Interventions

DRUG

Solifencin

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.

DRUG

Mirabegron

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.

Sponsors & Collaborators

  • Unidade Local de Saúde São João

    collaborator OTHER_GOV

  • Universidade do Porto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-31
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07711808 on ClinicalTrials.gov