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

13 luglio 2026 aggiornato da: Universidade do Porto

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Vescica iperattiva (OAB)

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

208

Fase

Fase 4

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: Low Anticholinergic Burden - Solifenacin Participants 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.	Droga: 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.
Comparatore attivo: Low Anticholinergic Burden - 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.	Droga: 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.
Comparatore attivo: High Anticholinergic Burden - 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.	Droga: 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.
Sperimentale: High Anticholinergic Burden - Solifenacin Participants 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.	Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
ICIQ OAB Lasso di tempo: From enrollment to 4 and 8 weeks	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).	From enrollment to 4 and 8 weeks

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Responder rate at Month 2 Lasso di tempo: From enrollment to 8 weeks	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.	From enrollment to 8 weeks
Change in frequency-volume chart parameters at Month 2 Lasso di tempo: From enrollment to 8 weeks	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.	From enrollment to 8 weeks
Treatment discontinuation rate Lasso di tempo: From enrollment to the end of 8 weeks	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.	From enrollment to the end of 8 weeks
Incidence of adverse events Lasso di tempo: From enrollment to the end of 8 weeks	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.	From enrollment to the end of 8 weeks

Altre misure di risultato

Misura del risultato	Misura Descrizione	Lasso di tempo
Treatment-by-DBI-stratum interaction on ICIQ-OAB change at Month 2 Lasso di tempo: From enrollment to the end of 8 weeks	This exploratory analysis examines whether the difference in effectiveness between the two treatments depends on a participant's baseline anticholinergic burden - that is, whether one treatment works comparatively better in the high-burden group (DBI ≥ 1) and the other in the low-burden group (DBI < 1). It is assessed by testing the statistical interaction between treatment arm and DBI stratum for the change in ICIQ-OAB total score at 2 months. This analysis is hypothesis-generating only; the study is not designed with sufficient statistical power to confirm such an interaction.	From enrollment to the end of 8 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidade do Porto

Collaboratori

Unidade Local de Saúde São João

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 luglio 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

13 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

BEAM

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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