Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative

Официальное название

Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)

Обзор

This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent. Eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission. Eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants. The study team hypothesizes that: * Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts. * Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.

Подробное описание

The coordinating center for this study is the Michigan Urological Surgery Improvement Collaborative (MUSIC), which is a physician-led Quality Improvement (QI) collaborative comprised of 44 urology practices and 260 urologists across the State of Michigan.

As sites are activated the registration will be updated.

Вмешательства

• Устройство Standard of care stent placement
  Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
• Другое No stent placement
  Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
• Другое Surveys
  All participants in the trial cohort and observational arms will be asked to complete survey instruments (evaluating their pain, quality of life, and experiences following ureteroscopy, as well as surveys evaluating their opinions and preferences around ureteral stenting, etc.). Participants will also have routine clinical data (preoperative, perioperative, and postoperative) to be collected and analyzed for research purposes.

Первичные конечные точки

• Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative [Срок оценки: Preoperative, Day 7-10]
• Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Score [Срок оценки: within 30 days after ureteroscopy]

Вторичные конечные точки (12)

• Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30 [Срок оценки: within 30 days after ureteroscopy]
• Number of Participants with Unplanned hospital admission within postoperative day 30 [Срок оценки: within 30 days after ureteroscopy]
• Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30 [Срок оценки: within 30 days after ureteroscopy]
• Number of Participants with Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30 [Срок оценки: within 30 days after ureteroscopy]
• Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30 [Срок оценки: within 30 days after ureteroscopy]
• Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30 [Срок оценки: within 30 days after ureteroscopy]
• PROMIS® Pain Interference (Short Form 6b) change at postoperative 4-6 weeks compared to preoperative [Срок оценки: preoperative, 4-6 weeks]
• PROMIS® Pain Intensity (Short Form 3a) change at postoperative day 7-10 preoperative [Срок оценки: preoperative, postoperative day 7-10]
• PROMIS® Pain Intensity (Short Form 3a) change at postoperative 4-6 weeks compared to preoperative [Срок оценки: preoperative, postoperative 4-6 weeks]
• National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative day 7-10 compared to preoperative [Срок оценки: preoperative, postoperative day 7-10]
• National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative 4-6 weeks compared to preoperative [Срок оценки: preoperative, postoperative 4-6 weeks]
• International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative day 7-10 [Срок оценки: Postoperative day 7-10]

Критерии участия

Критерии включения

• Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently)
• Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan
• Access to means of communication with the study team (email, text messaging, and/or telephone)
• Adequate independent cognitive function and English language proficiency to complete study surveys
• Written informed consent

Критерии исключения

• Planned bilateral ureteroscopy
• Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney
• Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)
• Anatomic or functional solitary kidney
• Planned secondary or staged ureteroscopy
• Planned use of ureteral access sheath
• Pregnancy
• Patients who use opiate medication daily for greater than 3 months to manage a painful condition

Second Stage Exclusion Criteria:

• ureteral perforation
• unanticipated anatomic abnormality
• greater than expected bleeding
• ureteral dilation greater than 12 French
• ureteral access sheath utilized
• failed ureteroscopy
• no or incomplete lithotripsy performed
• unable to complete case due to medical or anesthetic event.

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 · 16 центров

• University of Arizona — Tucson
• UF Health Shands Hospital — Gainesville
• Indiana University Department of Urology — Indianapolis
• University of Michigan Health System — Ann Arbor
• University of Michigan Health System — Brighton
• Cadillac Munson Hospital — Cadillac
• St. Joseph Health System Chelsea Hospital — Chelsea
• St. Joseph Mercy Health (Trinity) — Chelsea
• … и ещё 8 центров

Публикации

• Becker REN, Daignault-Newton S, Shoemaker E, Sitek D, Thelus JM, Clark S, Martin-Schwarze A, Spino C, Carlozzi NE, Meurer WJ, Sales AE, Dauw CA, Ghani KR. Stent Omission after Ureteroscopy and Lithotripsy (SOUL) in the Michigan Urological Surgery Improvement Collaborative (MUSIC): study protocol for a pragmatic prospective combined randomized and observational clinical trial. Trials. 2024 Dec 4;25 PMID 39633425

Идентификаторы

NCT: NCT05866081 · HUM00234740 · CER-2021C2-22856

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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