Comparison and Evaluation of USSQ (Ureteral Stent Symptom Questionnaire）, OABSS (Overactive Bladder Symptom Score), and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J（Double-J) Stents in Patients Who Underwent URL (Ureteroscopic Holmium Laser Lithotripsy）
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
研究概览
简要总结
Indwelling double-J ureteral stent (D-J stent) are routinely placed in patients who received ureteroscopic lithotripsy (URL) in Xinhua Hospital Urology Department. At present, three types of D-J stents, namely Cook/Kang Yi Bo(KYB)/Urovisionare are used, and usually removed in the day ward four weeks after surgery. This study intends to randomly divide patients with urolithiasis based on the preoperative OABSS (overactive bladder symptom score) questionnaire into three groups, namely Cook D-J stent group, KYB anti-reflux D-J stent group, Urovision trigonal D-J stent group, with corresponding D-J stent indwelled for 4 weeks respectively. The patient's USSQ ureteral stent symptom questionnaire）scale and OABSS scale were collected at 1 week, 4 weeks (before the removal of D-J stents), and 5 weeks (1 week after removal of D-J stents) after URL operation, and the D-J stents removed from the patients were collected, and their drainage and anti-reflux effects were measured in vitro.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abdominal CT scanning indicating ureteral stones or kidney stones that are less than 2 cm in diameter, and patients who are planning to undergo URL surgery.
- •Age between 18 and 80 years old and capable of providing written informed consent;
- •In general, the heart, lung, liver and kidney function are in well condition, able to tolerate surgical treatment, and comply with research requirements.
排除标准
- •Before the onset of urolithiasis, the patient has suffered from obvious overactive bladder syndrome, or chronic lower urinary tract infection, or urinary anatomic deformities, or had previously undergone urinary tract plastic surgery.
- •Other severe complications, infections, etc. that the researchers believe may make the subject unsuitable for this study.
- •The patient is not a local resident and insists on returning to his howetown for D-J stent removal after the URL operation（so that we are unable to retrieve the D-J stent and conduct the in vitro experiment）.
- •The patient refuses to sign the informed consent.
研究组 & 干预措施
Cook D-J stent group
Patients randomized to this group received Cook (Limerick, Ireland, USI-626-R) D-J stent.
Note: USI is an unexpandable acronym.
干预措施: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy (Device)
KYB anti-reflux D-J stent group
Patients randomized to this group received KYB (Shenzhen, China, 3201162) anti-reflux D-J stent.
干预措施: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy (Device)
Urovision trigonal D-J stent group
Patients randomized to this group received Urovision (Bad Aibling, Germany, ST-230726) trigonal D-J stent.
Note: ST is an unexpandable acronym. Aibling is a German region name.
干预措施: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy (Device)
结局指标
主要结局
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
时间窗: 5 weeks (1 week after removal of D-J stent)
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
时间窗: 1 week (after URL)
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
时间窗: 4 weeks (before removal of D-J stent)
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
次要结局
- Anti-reflux effect of D-J stents after being removed(4 weeks)
- Drainage effect of D-J stents after being removed(4 weeks)