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Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).
Title {1} | 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 of ureteral stent omission after ureteroscopic stone treatment |
Trial registration {2a and 2b}. | NCT05866081 [ClinicalTrials.gov; registered 19 May 2023] |
Protocol version {3} | Version 1.0 of 1st June, 2023 |
Funding {4} | This study is funded by the Patient-Centered Outcomes Research Institute (PCORI) Award (CER-2021C2-22,856). The Michigan Urological Surgery Improvement Collaborative is funded by Blue Cross Blue Shield of Michigan. |
Author details {5a} | RENB: Department of Urology, University of Michigan SDN: Department of Urology, University of Michigan ES: Department of Urology, University of Michigan DS: Patient Partner JMT: Department of Urology, University of Michigan SC: Department of Urology, University of Michigan CS: Department of Biostatistics, University of Michigan School of Public Health NEC: Center for Clinical Outcomes Development and Application, University of Michigan WM: Departments of Emergency Medicine and Neurology, University of Michigan AES: Sinclair School of Nursing, University of Missouri CAD: Department of Urology, University of Michigan KRG: Department of Urology, University of Michigan |
Name and contact information for the trial sponsor {5b} | Investigator-initiated clinical trial; K.R. Ghani (Principal Investigator)[email protected] |
Role of sponsor {5c} | The investigators were responsible for the trial design, drafting of this manuscript, and the decision to submit the trial protocol for publication. The study design, analysis, and interpretation of results presented in this publication are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors or Methodology Committee. |
Introduction
Background and rationale {6a}
In the USA, one in ten adults will have a kidney stone in their lifetime [1]. This chronic disease is recurrent and characterized by severe pain [2]. For patients unable to pass a stone, surgery is the mainstay of treatment [3]. With over 750,000 performed a year, ureteroscopy and lithotripsy are the most common procedure to remove or break up stones [4, 5]. At the end of ureteroscopy, a urologist may insert a temporary ureteral...