Comparing stent placement versus omission after kidney stone treatment
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
NA · University of Michigan · NCT05866081
This study is testing whether putting in a stent after kidney stone treatment helps patients feel better and need fewer extra doctor visits compared to not using a stent at all.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 792 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 16 sites (Tucson, Arizona and 15 other locations) |
| Trial ID | NCT05866081 on ClinicalTrials.gov |
What this trial studies
This multicenter trial evaluates patient-reported outcomes and healthcare utilization following ureteroscopy and lithotripsy for kidney stones, comparing outcomes between patients who receive a ureteral stent and those who do not. Participants will be randomized into two groups: one receiving standard stent placement and the other omitting the stent. Additionally, an observational cohort will allow for treatment decisions based on physician judgment while collecting patient feedback through surveys. The study aims to assess differences in pain levels and unplanned healthcare visits between the two approaches.
Who should consider this trial
Good fit: Ideal candidates are individuals undergoing unilateral ureteroscopy and lithotripsy for kidney stones measuring 10 mm or less.
Not a fit: Patients with planned bilateral ureteroscopy or those with certain anatomical abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient comfort and reduced healthcare utilization after kidney stone procedures.
How similar studies have performed: Previous studies have shown varying results regarding stent placement, making this approach both relevant and potentially novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Tucson, Arizona and 15 other locations
- University of Arizona — Tucson, Arizona, United States (RECRUITING)
- UF Health Shands Hospital — Gainesville, Florida, United States (RECRUITING)
- Indiana University Department of Urology — Indianapolis, Indiana, United States (RECRUITING)
- University of Michigan Health System — Ann Arbor, Michigan, United States (RECRUITING)
- University of Michigan Health System — Brighton, Michigan, United States (RECRUITING)
- Cadillac Munson Hospital — Cadillac, Michigan, United States (RECRUITING)
- St. Joseph Health System Chelsea Hospital — Chelsea, Michigan, United States (RECRUITING)
- St. Joseph Mercy Health (Trinity) — Chelsea, Michigan, United States (RECRUITING)
- Henry Ford Health System — Detroit, Michigan, United States (RECRUITING)
- Corewell Health Buttersworth Hospital — Grand Rapids, Michigan, United States (RECRUITING)
- E.W Sparrow Hospital — Lansing, Michigan, United States (RECRUITING)
- MyMichigan Medical Center Midland — Midland, Michigan, United States (RECRUITING)
- Michigan Institute of Urology Town Center Ambulatory Surgery Center — Troy, Michigan, United States (RECRUITING)
- Monte Fiore — Brooklyn, New York, United States (RECRUITING)
- Mount Sinai — New York, New York, United States (RECRUITING)
- UNC Hospital — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Khurshid Ghani, MD — University of Michigan
- Study coordinator: Elaina Shoemaker
- Email: Esekulos@med.umich.edu
- Phone: 734-764-3916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stone, Kidney, Stone Ureter, Unilateral ureteroscopy and lithotripsy, Ureteral stent, Pain assessment, Quality of life