The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
研究概览
简要总结
Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal excision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age : 20-65
- •Rectal cancer within 15cm from anal verge
- •Patients with more than 5 points decreased IIEF-5 after operation
- •Patients with sexual activity
排除标准
- •Preoperative IIEF-5 : ≤14
- •Recent MI, CVA, nitrate medication
- •Severe cardiovascular disease, psychiatric disease
- •Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
- •Renal dysfunction (Cr ≥2mg/dl)
研究组 & 干预措施
Control
Individuals who take placebo after total mesorectal excision
干预措施: Placebo drug (Drug)
Udenafil
Individuals who take udenafil after total mesorectal excision
干预措施: Udenafil (Drug)
结局指标
主要结局
Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
时间窗: Baseline, 12weeks, 24 weeks
* IIEF-5 questionnaire is used to assess male erectile function * IIEF-5 (5-item Version of the International Index of Erectile Function)is obtained by combining the scores of the responses to 5 questions. Each question is scored from 0-5 (1 questions is scored from 1-5) for IIEF-5 range of 1-25 points; lower numerical scores from the IIEF-5 questionnaire represnt greater severitt of erectile dysfunction.
次要结局
- Number of patients with adverse events during 24 weeks of the study(Baseline through 24 weeks)
- Change from baseline in SEP Q2,Q3 and GEQ(baseline, 12weeks, and 24 weeks)
研究者
Gyu-Seog Choi
Colorectal Cancer Center
Kyungpook National University Hospital