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临床试验/NCT04500860
NCT04500860已完成1 期

Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up

研究概览

简要总结

Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome

详细描述

90 female patients with overactive bladder syndrome divided into 3 groups group A subjected to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo. They are evaluated as using OAB symptoms score for 6 months follow up

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

性别
Female
接受健康志愿者

入选标准

  • any female with overactive bladder syndrome, urgency with or without urgency urinary incontinence

排除标准

  • Active Urinary tract infection
  • neurologic abnormality
  • Pure Stress urinary incontinence

研究组 & 干预措施

Group A Tadalafil 5 mg

Active Comparator

30 patients subjected to Daily dose of tadalafil 5mg

干预措施: Low dose tadalafil 5 mg (Drug)

Group B Tolterodine

Active Comparator

30 patients subjected to tolterodine 4 mg daily

干预措施: Tolterodine 4 Mg Oral Capsule, Extended Release (Drug)

Group C placebo

Placebo Comparator

30 patients subjected to placebo daily

干预措施: Placebo (Drug)

结局指标

主要结局

Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up

时间窗: 6 months

Evaluation of efficacy of tadalafil 5 mg

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samer Morsy

Urology lecturer

Kasr El Aini Hospital

研究点 (1)

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