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

Official title

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

Overview

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.

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.

Primary outcome measures

• ICIQ OAB [Time frame: From enrollment to 4 and 8 weeks]

Secondary outcome measures (4)

• Responder rate at Month 2 [Time frame: From enrollment to 8 weeks]
• Change in frequency-volume chart parameters at Month 2 [Time frame: From enrollment to 8 weeks]
• Treatment discontinuation rate [Time frame: From enrollment to the end of 8 weeks]
• Incidence of adverse events [Time frame: From enrollment to the end of 8 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07711808 · BEAM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗