Assessment of Efficacy of Mirabegron, Solifenacin, Tadalafil 5mg and Combination Therapy in Female Patients With Overactive Bladder: A Double Blinded Prospective Randomized Placebo -Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- overactive bladder symptoms score (OABSS)
研究概览
简要总结
The objective of this study is to compare the effectiveness of mirabegron, solifenacin, tadalafil (5mg), and their combination in relieving symptoms of overactive bladder (OAB) in a double-blinded prospective randomized placebo-controlled trial.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women from 18 to 65 years of age with LUTs due to OAB
排除标准
- •Severe cardiovascular disorders. \
- •Severe neurogenic dysfunction.
- •Drug administration which interfere with bladder function .
- •Abnormal bleeding profile.
- •A verified urinary tract infection as determined by urinalysis and/or urine culture during screening
研究组 & 干预措施
Group A : patients will receive mirabegron
patients will receive mirabegron
干预措施: Mirabegron (Drug)
Group B: patients will receive tadalafil 5mg
patients will receive tadalafil 5mg
干预措施: Tadalafil 5mg (Drug)
Group C: patients will receive solfenacin
patients will receive solfenacin
干预措施: Solfenacin (Drug)
结局指标
主要结局
overactive bladder symptoms score (OABSS)
时间窗: three months
OABSS is a symptom assessment questionnaire designed to quantify OAB symptoms into a single score The questionnaire consists of 4 questions on OAB symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and UUI (5 points). The total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity.
次要结局
未报告次要终点
研究者
Elsayed Abdelhalim Elsayed
assistant lecturer, urology department, Kafrelsheikh university
Kafrelsheikh University