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NCT05866081
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
NA trial testing Standard of care stent placement in Stone, Kidney in 792 participants. Currently enrolling.
1 May 2026
Quick facts
| Lead sponsor | University of Michigan |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 792 |
| Start date | 1 June 2023 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 May 2026 |
| Sites | 16 locations across United States |
Drugs / interventions tested
- Standard of care stent placement
- No stent placement
- Surveys
Conditions studied
- Stone, Kidney — all drugs for Stone, Kidney →
- Stone Ureter — all drugs for Stone Ureter →
Sponsor
University of Michigan
Who can join
18 and older, any sex, with Stone, Kidney or Stone Ureter. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Becker REN, Daignault-Newton S, Shoemaker E, Sitek D, et al · · 2024 · cited 7× · PMID 39633425 · DOI 10.1186/s13063-024-08587-8 -
Rationale and protocol for a prospective clinical trial enrollment improvement hybrid study within a trial.
Lewicki P, Clark S, Shoemaker E, Wang B, et al · · 2025 · PMID 41050879 · DOI 10.1016/j.conctc.2025.101548 -
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
Becker RE, Daignault-Newton S, Shoemaker E, Sitek D, et al · · 2024 · DOI 10.21203/rs.3.rs-4613403/v1
Verify or expand the search:
- PubMed search for NCT05866081
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Stone, Kidney
Currently open trials in the same condition.
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- NCT06860113 — Evaluation of Retrograde Intra Renal Surgery in the T-tilted Position · NA · recruiting
- NCT07068087 — Silodosin in Facilitating Flexible Uretroscopy · NA · active not recruiting
- NCT06797466 — Three Dimensional Virtual Reconstruction (3D) in Percutaneous Nephrolithotomy · NA · recruiting
Other University of Michigan trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05866081 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Michigan
- Last refreshed: 15 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05866081.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing