Ureteral access sheath: omitting versus placing a stent after ureteroscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients who consent will complete baseline patient-reported outcome questionnaires and undergo ureteroscopy using a ureteral access sheath. The operating urologist will grade the ureter for injury using the Post-Ureteroscopic Lesion Scale (PULS), and only those with PULS 0 or 1 will be randomized 1:1 to stent omission or stent placement. When a stent is placed, the type and whether a tether (string) is left will be left to the surgeon's discretion. The trial will compare patient-reported pain outcomes (PROMIS Pain Interference and Pain Intensity) and 30-day healthcare utilization between the two arms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Planned ureteroscopy using a Ureteral Access Sheath (UAS) for treatment of unilateral kidney and/or ureteral stones in patients that have an existing ureteral stent (pre-stented)
* Planned treatment of unilateral renal and/or ureteral stones, in a single procedure.
* Renal stone defined as only renal location of stone(s)
* Ureteral stone defined as ureteral only location of stone(s)
* Ureteral and renal stone(s)
* No evidence of significant ureteral injury on intra-operative assessment (Post-Ureteroscopy Lesion Scale (PULS) Grade 0 or 1)
* Ability and willingness to complete and adhere to survey questions and responses throughout study duration.

Exclusion Criteria:

* Pregnancy
* Ureteric injury during ureteroscopy (PULS ≥ Grade 2)
* Evidence of ureteral stricture
* Anatomical abnormalities (e.g., solitary, horseshoe, fused crossed ectopia, pelvic kidney, urinary diversion)
* Known planned secondary or staged procedure
* Indwelling nephrostomy tube
* Bilateral ureteroscopy

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Khurshid Ghani, MD — University of Michigan
• Study coordinator: MUSIC Coordinating Center
• Email: esekulos@med.umich.edu
• Phone: 734-232-4906

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.