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

Recruiting now · Not applicable

Conditions studied: Stone, Kidney, Stone Ureter

In brief

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.

Key facts

Study ID

NCT05866081

Run by

University of Michigan

People needed

792

Starts

2023-06-01

Expected to finish

2026-05-01

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States (enrolling)
• UF Health Shands Hospital — Gainesville, Florida, United States (enrolling)
• Indiana University Department of Urology — Indianapolis, Indiana, United States (enrolling)
• University of Michigan Health System — Ann Arbor, Michigan, United States (enrolling)
• University of Michigan Health System — Brighton, Michigan, United States (enrolling)
• Cadillac Munson Hospital — Cadillac, Michigan, United States (enrolling)
• St. Joseph Health System Chelsea Hospital — Chelsea, Michigan, United States (enrolling)
• St. Joseph Mercy Health (Trinity) — Chelsea, Michigan, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• Corewell Health Buttersworth Hospital — Grand Rapids, Michigan, United States (enrolling)
• E.W Sparrow Hospital — Lansing, Michigan, United States (enrolling)
• MyMichigan Medical Center Midland — Midland, Michigan, United States (enrolling)
• Michigan Institute of Urology Town Center Ambulatory Surgery Center — Troy, Michigan, United States (enrolling)
• Monte Fiore — Brooklyn, New York, United States (enrolling)
• Mount Sinai — New York, New York, United States (enrolling)
• UNC Hospital — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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