To Explore the Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and Develop Its Urinary Biomarker
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 主要终点
- Change in participant's urinary beta-3 adrenoreceptor from baseline to 12 weeks after treatment
研究概览
简要总结
About one to two million women in Taiwan suffers from overactive bladder (OAB). The most commonly used anti-muscarinic drugs have a high rate of side effects. While beta-3 adrenoceptor agonist, Mirabegron, has far fewer side effects, there are no consensus on whether it can be used as first-line treatment. The investigator's preliminary study showed that the concentration of beta-3 adrenoceptor in the urine of OAB patients is higher than that in the normal control group, so comparing urinary beta-3 adrenoceptor concentration of OAB patients before and after treatment may be used as a biomarker of therapeutic effectiveness. The results of this study will be of great help in understanding the effectiveness of Mirabegron and formulating OAB treatment plans.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis compatible with 2002 ICS for overactive bladder syndrome
- •Symptoms persisted for more than 3 months
- •Completed pre-treatment urodynamic study
- •Has plans for treatment with Mirabegron or Solifenacin due to clinical symptoms
- •Patient is willing to cooperate with study including follow up and complete questionnaire surveys
排除标准
- •Has stress urinary incontinence
- •Pelvic organ prolapse
- •Interstitial cystitis
- •Constipation
- •Gastroesophageal reflux disease
- •Prior failed medical treatment for overactive bladder syndrome
- •Uncontrolled hypertension
- •Currently pregnant
- •Using other medications for overactive bladder syndrome
研究组 & 干预措施
Overactive bladder with Mirabegron
100 patients with overactive bladder syndrome, diagnosed according to 2002 ICS diagnosis will undergo 12 weeks of Mirabegron 50mg once daily use. Evaluation include questionnaire survey and urine beta-3 adrenoceptor concentration.
干预措施: Mirabegron 50 MG (Drug)
Overactive bladder with Solifenacin
100 patients with overactive bladder syndrome, diagnosed according to 2002 ICS diagnosis will undergo 12 weeks of Solifenacin 5mg once daily use. Evaluation include questionnaire survey and urine beta-3 adrenoceptor concentration.
干预措施: Solifenacin Succinate 5 MG (Drug)
结局指标
主要结局
Change in participant's urinary beta-3 adrenoreceptor from baseline to 12 weeks after treatment
时间窗: 12 weeks
Concentrations of urinary beta-3 adrenoceptor levels will be analyzed for 1)before and after treatment of patients with overactive bladder syndrome treated with Mirabegron; 2)before and after treatment patients with overactive bladder syndrome treated with Solifenacin; 3)patients with urinary tract infection, and 4)control (subjects without lower urinary tract symptoms).
次要结局
- Effect on the participant's life after treatment with Mirabegron and Solifenacin 6 months after treatment.(6 months)
- Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity after 12 weeks of treatment(12 weeks)
- Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity 6 months after treatment.(6 months)
- Change in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.(12 weeks)
- Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.(12 weeks)
- Change in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment(6 months)
- Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.(6 months)
- The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.(12 weeks)
- The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.(6 months)
- Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment(12 weeks)
- Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment.(6 months)
- Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment(12 weeks)
- Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment(6 months)
- Effect on the participant's life after treatment with Mirabegron and Solifenacin after 12 weeks of treatment.(12 weeks)
- The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin after 12 weeks of treatment.(12 weeks)
- The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin 6 months after treatment.(6 months)
研究者
Ching-Chung Liang
Professor
Chang Gung Memorial Hospital