NCT05490082Unknown3 期
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dysuria
研究概览
简要总结
A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation
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
- Double (Investigator, Outcomes Assessor)
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
- •Patients older than age 18 years.
- •Able to provide an informed consent.
- •Denovo or recurrent cases with intermediate and high risk NMIBC eligible for intravesical BCG immunotherapy.
- •Persistent LUTS after intravesical BCG induction.
排除标准
- •International Prostate symptom score (IPSS) greater than
- •Post-void residual (PVR) volume greater than 50 ml.
- •Use of medications for overactive bladder.
- •Pelvic surgery within the previous 6 months.
- •Hypersensitivity for BCG or any of the above mentioned drugs.
- •Tumor recurrence during follow up period.
- •Other medical conditions that would be adversely affected by anticholinergics such as history of urinary retention due to BPH(Benign prostatic hyperplasia), constipation and history of narrow angle glaucoma.
研究组 & 干预措施
Solifenacin arm
Active Comparator
10 mg PO once daily
干预措施: Mirabegron, Propevirine, Solifenacin (Drug)
Placebo arm
Placebo Comparator
starch tablet once daily
干预措施: Mirabegron, Propevirine, Solifenacin (Drug)
Mirabegron arm
Active Comparator
50 mg PO once daily
干预措施: Mirabegron, Propevirine, Solifenacin (Drug)
Propevirine arm
Active Comparator
15 mg PO twice daily
干预措施: Mirabegron, Propevirine, Solifenacin (Drug)
结局指标
主要结局
Dysuria
时间窗: 3 months
Compare the percentage of reduction of dysuria as measured by Pain Visual Analouge Score at 3 month follow up after using propiverine, mirabegron and solifenacin versus placebo.
次要结局
未报告次要终点
研究者
Ali Elmenair
principle investigator
Mansoura University
研究点 (1)
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