Comparisons of Urodynamic Effects, Urinary Nerve Growth Factor Levels and Outcomes in Female Overactive Bladder Patients After 3-month Versus 6-month Solifenacin Treatment: a Randomized Prospective Study
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The rate of normalized urodynamic findings
研究概览
简要总结
To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.
详细描述
Overactive bladder syndrome (OAB), with or without urge incontinence, is characterized by urinary urgency, frequency and nocturia. Thus, patients with OAB could be considered to have a reduced quality of life. Patients with overactive bladder syndrome have a higher risk of falling and fracture due to nocturia. OAB affects around 17 % of female population. At present, muscarinic receptor antagonists are the first-line pharmacotherapeutic agents for OAB. However, discontinuation of the treatment often results in symptom relapse. Until now, optimal duration of the treatment and durability of the efficacy have not been determined. We plan to use urodynamic studies outcome to evaluate therapeutic effect, with the change of urinary nerve growth factor level. This study is a randomized prospective study, comparing female OAB patient after 3 months and 6 months of antimuscarinic treatment.
The purpose of this study is to investigate the difference of urodynamic effects, therapeutic effect and urinary urinary nerve growth factor level between OAB females after 3 months and 6 months antimuscarinic treatment.
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
- 20 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have overactive bladder syndrome
排除标准
- •Women who are less than 20 year-old
研究组 & 干预措施
Solifenacin for 12 weeks group
Solifenacin (5 mg qd) for 12 weeks
干预措施: Solifenacin for 12 weeks (Drug)
Solifenacin for 24 weeks group
Solifenacin (5 mg qd) for 24 weeks
干预措施: Solifenacin for 24 weeks (Drug)
结局指标
主要结局
The rate of normalized urodynamic findings
时间窗: 6 months
The rate of normalized urodynamic finding after antimuscarinics
次要结局
- The cure rate of overactive bladder(24 weeks)
- The recurrence rate of overactive bladder(2.5 years)
- The difference of urine nerve growth factor level(24 weeks)
