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临床试验/NCT01876186
NCT01876186Unknown4 期

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Solifenacin (5 mg qd) for 12 weeks

干预措施: Solifenacin for 12 weeks (Drug)

Solifenacin for 24 weeks group

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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