Access Sheath and Stent Trial

Официальное название

Access Sheath and stENT Trial

Обзор

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.

Вмешательства

• Другое Surveys
  Surveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information.

Первичные конечные точки

• Differences in PROMIS Pain Interference [Срок оценки: Baseline (before procedure), 7-10 days after procedure]

Вторичные конечные точки (12)

• Differences in PROMIS Pain intensity [Срок оценки: 7-10 days after procedure]
• Differences in PROMIS Pain intensity [Срок оценки: 4-6 weeks after procedure]
• Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10 [Срок оценки: 7-10 days after procedure]
• Differences in Urinary Symptoms based on the Lower Urinary Tract Dysfunction Research Network (LURN) Symptom index (SI)-10 [Срок оценки: 4-6 weeks after procedure]
• Difference in PROMIS Social Roles & Activities [Срок оценки: Daily after procedure (10 days or up to stent removal)]
• Difference in Pain intensity assessment based on the Visual analog scale [Срок оценки: Daily after procedure (10 days or up to stent removal)]
• Treatment Satisfaction based on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-S) [Срок оценки: 7-10 days post procedure and 4 weeks]
• Count of days off work Patient [Срок оценки: Day 7 post procedure and 4 weeks post procedure]
• Count of days off work Caregiver [Срок оценки: Day 7 post procedure and 4 weeks post procedure]
• Composite healthcare utilization metric within 30 days (WinRatio) [Срок оценки: Up to 30 days after procedure]
• Abnormal imaging findings within 60 days [Срок оценки: within 60 days of procedure]
• Stone-free rates within 60 days [Срок оценки: within 60 days of procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07297953 · HUM00264257

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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