A Prospective Randomized Trial Comparing the Effects of Anti-reflux Versus Standard Ureteral Stents on Male Sexual Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- change in IIEF score
研究概览
简要总结
Objective: To compare the effectiveness of anti-reflux ureteral stents on improving erectile function and quality of life of patients with ureteral stents.
Methods and Populations: A total of 100 male patients who required ureteral stent placement after ureteroscopic lithotripsy were randomly assigned to two groups: those in Group T (n=50) received a standard double-J-stent, while those in Group A (n=50) underwent implantation with anti-reflux ureteral stent. Follow up for 8 weeks after surgery, including reproductive hormones and inflammation marks, Beck's depression scale, IIEF and statistics on the frequency of symptoms such as hematuria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male sexually active patients with unilateral ureteral calculi who underwent ureteroscopy with laser lithotripsy and needed post-procedure stent
排除标准
- •Patients were excluded if they included the following criteria: (1) age under 18 or over 50 years, (2) history of previous ureteral stenting, (3) bilateral stents, (4) moderate or severe ureteral stricture need long-term stenting (on regular exchange), (5) bladder pathology and overactive bladder, (6) symptomatic benign prostatic hyperplasia, (7) moderate or severe urinary tract infection, (8) moderate or severe cardiovascular disease, hepatic dysfunction and diabetes, (9) previous use of selective alpha-1-blocker and/or antimuscarinic agent, (10) pre-op IIEF-5 ≤ 21.
研究组 & 干预措施
Group A
anti-reflux ureteral stent(INNOVEX, Shanghai, China)
干预措施: Routine laser lithotripsy (Procedure)
Group-T
standard double-J-stent
干预措施: Routine laser lithotripsy (Procedure)
结局指标
主要结局
change in IIEF score
时间窗: Patients were followed up postoperatively according to a bi-weekly schedule, with clinical assessments at 2, 4, 6, and 8 weeks
次要结局
未报告次要终点
研究者
Rong Wang
Chief Physician
Zhangjiagang First People's Hospital