A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Urethral Drug Balloon Catheter in the Treatment of Urethral Stricture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Procedural success
研究概览
简要总结
To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture.
详细描述
This is a prospective, multicenter, randomized controlled, and superiority study. The two groups were randomly selected into a total of 150 subjects (75 in the test group and 75 in the control group) according to 1:1. The test group was treated with urethral drug balloon catheter from Lepu Medical Technology (Beijing) Co.,Ltd., while the control group was treated with direct vision internal urethrotomy (DVIU).
All subjects were followed up at 1, 3 and 6 months post-procedure, and the efficacy of urethral drug balloon catheter will be evaluated with the success rate of operation at 6 months as the main end point. Observe the occurrence of complications and other indicators to make a reliable evaluation of the safety of urethral drug balloon catheter.
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 85 years old, male patients;
- •Urethral stricture was confirmed by transurethral angiography, and the length of stricture was less than 2 cm;
- •Maximum urine flow rate (Qmax)<15 ml/s;
- •There are obvious symptoms of urinary tract stricture such as slow urine rheology, difficulty in urination and incomplete urination;
- •International Prostate Symptom Score (IPSS) ≥ 13;
- •The guide wire must be able to pass through the stenosis segment;
- •Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, can independently complete effective questionnaires, and are willing to conduct clinical follow-up according to the research requirements.
排除标准
- •Patients with multiple stenotic lesions;
- •Patients with a history of allergy to paclitaxel and contrast agents, or patients undergoing treatment with drugs that may antagonize paclitaxel;
- •Patients who have undergone hypospadias repair, urethroplasty, stricture expansion or incision in the past 3 months;
- •Urethral stricture caused by the following causes: bacterial urethritis, untreated gonorrhea, lichen sclerosus or dry glans obliterans;
- •There are other diseases that can cause lower urinary tract symptoms, such as overactivity of bladder, neurogenic bladder dysfunction, etc;
- •There are adverse factors for catheter insertion;
- •Patients with artificial penis or urethral sphincter, or urethral or prostate stent;
- •Patients who have been diagnosed with urethra cancer, bladder cancer cancer or prostate cancer, or who have experienced pelvic radiotherapy in the past 2 years;
- •For patients with severe renal insufficiency, their serum creatinine is more than 2.5mg/dL or they are undergoing hemodialysis;
- •Patients with severe lung disease, cardiovascular disease, coagulation dysfunction and contraindication of anesthesia;
- •Patients with poor control of diabetes (hemoglobin A1c>8.0%);
- •Patients with active urinary stones in the past 6 months;
- •Patients who are not suitable for direct vision internal urethrotomy;
- •Patients with pregnancy preparation plan;
- •Patients who are participating in clinical trials of other drugs or medical devices and have not reached their main endpoint;
- •Patients who cannot participate in the clinical trial due to other reasons considered by the investigator.
结局指标
主要结局
Procedural success
时间窗: 6 months post-procedure
no reoperation or instrument intervention is required, and 16F bladder flexible mirror or 16F catheter can pass through the stenosis
次要结局
- Change in the International Prostate Symptom Score (IPSS)(1, 3 and 6months)
- Change in the Quality of life index score (QOL)(1, 3 and 6months)
- Residual urine volume (PVR)(6 months post-procedure)
- Number of re-interventions after operation(1, 3, 6 months post-procedure)
- Maximum urinary flow rate (Qmax)(1 and 6 months post-procedure)
- Postoperative complications(1,3,6 months post-procedure)