Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
Overactive bladder is a common problem among adult women. Darifenacin is an antimuscarinic drug that is frequently used as part of the management of the condition. However, current evidence backing its use is limited. This study aims to address Darifenacin's effectiveness in adjunct to physiotherapy in treating symptoms due to overactive bladder.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with overactive bladder as diagnosed and confirmed by a urologist.
- •Able to answer the ICIC, King's Health Questionnaire and Overactive Bladder Questionnaire.
- •Able and willing to receive urodynamic studies.
排除标准
- •History of pelvic radiotherapy.
- •Recent pelvic surgery (<1 year).
- •History of anti-incontinence surgery.
- •Pregnancy.
研究组 & 干预措施
Darifenacin + Physiotherapy
Patients allocated to this group will receive Darifenacin 7.5mg daily in addition to physiotherapy for 12 weeks. This dose may be increased up to 7.5mg twice daily in follow-up visits in cases of refractory symptoms.
干预措施: Darifenacin (Drug)
Darifenacin + Physiotherapy
Patients allocated to this group will receive Darifenacin 7.5mg daily in addition to physiotherapy for 12 weeks. This dose may be increased up to 7.5mg twice daily in follow-up visits in cases of refractory symptoms.
干预措施: Physiotherapy (Procedure)
Physiotherapy
Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill.
干预措施: Physiotherapy (Procedure)
结局指标
主要结局
Quality of Life
时间窗: 12 weeks
Overall quality of life as established by the Overactive Bladder Questionnaire.
次要结局
- Overactive Bladder Symptoms(12 weeks)
- Adverse Events(12 weeks)
研究者
Felipe Martinez
M.D., M.Sc.
Universidad de Valparaiso