Differences in Postoperative Symptoms With Four Ureteral Stents

Официальное название

Randomized Clinical Trial Evaluating Differences in Postoperative Symptoms With 6Fr Percuflex Ureteral Stents Versus 6Fr Tria Ureteral Stents Versus 4.8Fr Percuflex Ureteral Stents Versus 4.8Fr Tria Ureteral Stents After Laser Lithotripsy of Renal and Ureteral Stones

Обзор

This is a prospective randomized controlled trial designed to assess the differences in postoperative symptoms related to placement of a 6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents, 4.8Fr Percuflex ureteral stents, and 4.8Fr Tria ureteral stents after ureteroscopy with laser lithotripsy for treatment of upper tract urinary stones. 272 participants will be enrolled and will be on study for up to approximately 10 weeks.

Подробное описание

The investigators will compare Ureteral Stent Symptom Questionnaire (USSQ) scores with each ureteral stent. Laser lithotripsy is a surgical procedure performed during stone surgeries. The Percuflex ureteral stent and Tria ureteral stent are FDA approved and clinically used in the United States.

A total of 3 clinic visits (i.e., pre-operative visit, the stent removal 1-2 weeks after surgery, and one post-operative visit 3-6 weeks after surgery) in addition to the surgery will be needed for this study. The patient's demographic information and medical background data will be collected from the medical record.

The USSQ will be administered twice:

1. At the time of stent removal (1-2 weeks after surgery ) (This is standard of care) 2. At the first postoperative follow-up after stent removal (3-6 weeks) (This is the standard of care).

The following information will be collected as secondary outcomes:

1. WisQOL which will be administered three times. It is UW standard of care for stone patients to complete the WisQOL at every clinic visit. 2. ER visits documented in patients chart 3. Unscheduled clinic follow-up documented in patient chart 4. Additional prescriptions for stent related symptoms documented by patient chart 5. Stent complications by fluoroscopy or image 6. Physician evaluation of the stent. Physicians will complete a one page survey at the end of the case evaluating the stent.

Вмешательства

• Устройство 6Fr Percuflex ureteral stents
  The Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
• Устройство 6Fr Tria ureteral stents
  The Tria stent is a new stent that is designed to soften at body temperature after placement, with an additional coating that prevents calcium and magnesium build up. This is intended to increase patient tolerability of the stent. 6 Fr is the diameter.
• Устройство 4.8Fr Tria ureteral stents
  The Tria stent is a new stent that is designed to soften at body temperature after placement, with an additional coating that prevents calcium and magnesium build up. This is intended to increase patient tolerability of the stent. 4.8 Fr is the diameter.
• Устройство 4.8Fr Percuflex ureteral stents
  The Percuflex stent is a 4.8Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.

Первичные конечные точки

• Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms [Срок оценки: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)]
• Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain Index [Срок оценки: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)]
• Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health [Срок оценки: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)]
• Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance [Срок оценки: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)]
• Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual matters [Срок оценки: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)]
• Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms [Срок оценки: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)]
• Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain index [Срок оценки: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)]
• Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health [Срок оценки: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)]
• Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance [Срок оценки: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)]
• Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual Matters [Срок оценки: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)]

Вторичные конечные точки (6)

• Change in Quality of Life measured by WISQOL Scores [Срок оценки: pre-operative visit (baseline), the stent removal 1-2 weeks after surgery (up to 4 weeks on study), and one post-operative visit 3-6 weeks after surgery (up to 10 weeks on study)]
• Number of Emergency Room Visits [Срок оценки: up to 10 weeks]
• Number of Unscheduled Clinic Follow-Ups [Срок оценки: up to 10 weeks]
• Summary of Additional Prescriptions for Stent-Related Symptoms [Срок оценки: up to 10 weeks]
• Summary of Stent Complications [Срок оценки: up to 10 weeks]
• Physician Evaluation of Stent: Survey Scores [Срок оценки: up to 10 weeks]

Критерии участия

Критерии включения

• Patients with renal or ureteral urinary stones who require endoscopic treatment and stent placement in the outpatient operating room.

Критерии исключения

• Pregnant patients
• Patients with transplant kidneys
• Patients with irreversible coagulopathy
• Patients with known ureteral stricture disease
• Non-English speaking, vulnerable patients such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.
• Patients with planned staged procedures.
• Patients who have stent placed before surgery.

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

Лечение

Центры проведения

США · 1 центр

• University of Wisconsin School of Medicine and Public Health — Madison

Идентификаторы

NCT: NCT06083051 · 2023-0832 · Urology · Protocol Version 10/28/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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