Burden and Efficacy of Anticholinergic vs Mirabegron in Overactive Bladder - A Randomized Controlled Study (BEAM)
2026年7月13日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
208
段階
- フェーズ 4
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
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.
|
|
アクティブコンパレータ：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.
|
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.
|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ICIQ OAB
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Responder rate at Month 2
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment-by-DBI-stratum interaction on ICIQ-OAB change at Month 2
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年8月1日
試験登録日
最初に提出
2026年7月13日
QC基準を満たした最初の提出物
2026年7月13日
最初の投稿 (実際)
2026年7月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月17日
QC基準を満たした最後の更新が送信されました
2026年7月13日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BEAM
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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