BURDEN AND EFFICACY OF ANTICHOLINERGIC VS MIRABEGRON IN OVERACTIVE BLADDER - A RANDOMIZED CONTROLLED STUDY
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 208
- 主要终点
- ICIQ OAB
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
ICIQ OAB
时间窗: 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).
次要结局
- Responder rate at Month 2(From enrollment to 8 weeks)
- Change in frequency-volume chart parameters at Month 2(From enrollment to 8 weeks)
- Treatment discontinuation rate(From enrollment to the end of 8 weeks)
- Incidence of adverse events(From enrollment to the end of 8 weeks)