Ureteral access sheath: omitting versus placing a stent after ureteroscopy
Access Sheath and stENT Trial
We will test if leaving out a ureteral stent after ureteroscopy with an access sheath works as well as placing a stent for pre-stented adults with kidney or ureteral stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07297953 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults who are pre-stented and planned for unilateral ureteroscopy with a ureteral access sheath for kidney or ureteral stones and who can complete study surveys and follow-up.
Not a fit: Patients with intraoperative ureteral injury (PULS ≥2), ureteral strictures, certain anatomical abnormalities, pregnancy, or those not pre-stented are unlikely to benefit from the stent-omission approach tested here.
Why it matters
Potential benefit: If successful, some patients could avoid the discomfort and inconvenience of a ureteral stent while keeping similar pain and quality-of-life outcomes and reducing short-term healthcare use.
How similar studies have performed: Previous randomized and observational studies have suggested stent omission can be safe and reduce stent-related symptoms after uncomplicated ureteroscopy, though results vary by patient selection and technique.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
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.