Recurrence of Symptoms of Overactive Bladder After Weaning Versus Sudden Stopping of Anticholinergics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- improvement
研究概览
简要总结
Our study included 60 patients with idiopathic OAB and treated with solifenacin 5mg twice daily for one month. After improvement of their condition, we divided the responders into 2 groups, group I stopped the drug suddenly, while group II underwent gradual weaning of the drug.
详细描述
We started an open-label, prospective, two-arm, randomized controlled trial at Beni-Suef University, from January 2018 to January 2019, including 60 patients suffering from OAB symptoms. Patients were recently diagnosed with idiopathic OAB which was not treated prior to enrollment. All participants signed written informed consents. The study protocol was approved by the ethics committee of our faculty. Patients were allocated into 2 equal groups (30 patients in each group) according to a computer-generated random numeric table after exclusion of those who are not eligible or refused to be included in the study
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
- •OAB patients.
- •Recently diagnosed.
排除标准
- •Previous trials of treatment
- •UTI, stones, tumors, or Infravesical obstruction.
研究组 & 干预措施
sudden stopping
patients were followed up after 1 and 3 months from stopping the drug,
干预措施: Solifenacin Succinate 5 MG (Drug)
Weaning
patients were followed up after 1and 3 months from the end of gradual weaning
干预措施: Solifenacin Succinate 5 MG (Drug)
结局指标
主要结局
improvement
时间窗: 1 month
decrease voiding times
次要结局
- recurrence of symptoms(3 months)
研究者
Ahmed M Abdelbary, MD
Associate professor
Beni-Suef University