Access Sheath and stENT Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Differences in PROMIS Pain Interference
研究概览
简要总结
The study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy.
Participants that consent for the study will complete baseline PRO questionnaires. A UAS will be used during surgery, and the size left to the discretion of the surgeon. At the end of the procedure, the urologist will evaluate the ureter for iatrogenic injury, and the ureter will be graded using the Post Ureteroscopic Lesion Scale (PULS). Patients assessed with PULS 0 and PULS 1 will meet 2nd stage eligibility and will be randomized 1:1 to either stent omission or stent placement. When a stent is placed, the stent type and decision to leave a string (tether) will be at the operating urologist's discretion.
Hypothesis:
- stent omission arm will be non-inferior to stent placement in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity, and have lower 30-day healthcare utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Patients will be informed of the presence or absence of a stent immediately following participants surgery.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Planned ureteroscopy using a Ureteral Access Sheath (UAS) for treatment of unilateral kidney and/or ureteral stones in patients that have an existing ureteral stent (pre-stented)
- •Planned treatment of unilateral renal and/or ureteral stones, in a single procedure.
- •Renal stone defined as only renal location of stone(s)
- •Ureteral stone defined as ureteral only location of stone(s)
- •Ureteral and renal stone(s)
- •No evidence of significant ureteral injury on intra-operative assessment (Post-Ureteroscopy Lesion Scale (PULS) Grade 0 or 1)
- •Ability and willingness to complete and adhere to survey questions and responses throughout study duration.
排除标准
- •Pregnancy
- •Ureteric injury during ureteroscopy (PULS ≥ Grade 2)
- •Evidence of ureteral stricture
- •Anatomical abnormalities (e.g., solitary, horseshoe, fused crossed ectopia, pelvic kidney, urinary diversion)
- •Known planned secondary or staged procedure
- •Indwelling nephrostomy tube
- •Bilateral ureteroscopy
结局指标
主要结局
Differences in PROMIS Pain Interference
时间窗: Baseline (before procedure), 7-10 days after procedure
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The scores range from 6-30 with a higher score indicating greater interference.
次要结局
- Differences in PROMIS Pain intensity(4-6 weeks after procedure)
- Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10(4-6 weeks after procedure)
- Count of days off work Patient(Day 7 post procedure and 4 weeks post procedure)
- Count of days off work Caregiver(Day 7 post procedure and 4 weeks post procedure)
- Difference in PROMIS Social Roles & Activities(Daily after procedure (10 days or up to stent removal))
- Difference in Pain intensity assessment based on the Visual analog scale(Daily after procedure (10 days or up to stent removal))
- Treatment Satisfaction based on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-S)(7-10 days post procedure and 4 weeks)
- Composite healthcare utilization metric within 30 days (WinRatio)(Up to 30 days after procedure)
- Abnormal imaging findings within 60 days(within 60 days of procedure)
- Stone-free rates within 60 days(within 60 days of procedure)
- Differences in PROMIS Pain Interference(4-6 weeks after procedure)
- Differences in PROMIS Pain intensity(7-10 days after procedure)
- Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10(7-10 days after procedure)
研究者
Khurshid Ghani
Clinical Professor of Urology
University of Michigan