Efficacy and Tolerability of Tadalafil 5mg Once Daily Versus Darifenacin for Ureteric Stent Related Symptoms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- change in stent related lower urinary tract symptoms (LUTS)
研究概览
简要总结
This randomized, crossover clinical trial evaluated the efficacy and safety of tadalafil compared with darifenacin in managing lower urinary tract symptoms (LUTS) and pain related to indwelling ureteric stents. A total of 150 patients who underwent ureteric stent insertion after endoscopic treatment of ureteric stones were enrolled. Patients were randomized into two groups: Group 1 received tadalafil 5 mg once daily for 3 weeks, followed by a 1-week washout, then darifenacin 7.5 mg once daily for 3 weeks. Group 2 received the reverse sequence.
The primary outcome was change in LUTS as measured by a shortened International Prostate Symptom Score (IPSS). The secondary outcome was stent-related pain measured by the Numeric Pain Rating Scale (NPRS). Drug safety and tolerability were also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18-40 years
- •Patient with ureteric stent size 6 Fr-26 cm post endoscopic procedure.
排除标准
- •Known prostatic patient with LUTS
- •Pregnant or lactating women
- •Recurrent urinary tract infection.
- •Neurological diseases.
研究组 & 干预措施
Group 1
in the 1st phase Group 1 received Tadalafil 5 mg tab once daily orally and switched to Darifenacin 7.5 mg once daily orally in the 2nd phase
干预措施: Tadalafil 5Mg Tab (Drug)
Group 1
in the 1st phase Group 1 received Tadalafil 5 mg tab once daily orally and switched to Darifenacin 7.5 mg once daily orally in the 2nd phase
干预措施: Darifenacin 7.5 MG (Drug)
Group 2
in the 1st phase: group 2 received darifenacin 7.5 mg once daily orally and switched to tadalafil 5 mg once daily orally in the 2nd phase of the study
干预措施: Tadalafil 5Mg Tab (Drug)
Group 2
in the 1st phase: group 2 received darifenacin 7.5 mg once daily orally and switched to tadalafil 5 mg once daily orally in the 2nd phase of the study
干预措施: Darifenacin 7.5 MG (Drug)
结局指标
主要结局
change in stent related lower urinary tract symptoms (LUTS)
时间窗: 3 weeks
Change from baseline in stent-related symptoms, measured by a shortened International Prostate Symptom Score (IPSS), including incomplete emptying (Q1) and storage domain (Q2, Q4, Q7). The score was calculated (minimum 0 and maximum 20) according to patients' answers to the questions Higher scores indicate worse symptoms.
Change in numerical Pain rating score (NPRS)
时间窗: 3 weeks
Change from baseline in ureteric stent-related pain, measured by the Numeric Pain Rating Scale (0 = no pain, 10 = worst pain).
次要结局
- Incidence of Adverse Events(Throughout the 7-week study period (3 weeks first drug, 1 week washout, 3 weeks second drug))