Actively Recruiting
Access Sheath and Stent Trial
Led by University of Michigan · Updated on 2025-12-22
184
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy. Participants that consent for the study will complete baseline PRO questionnaires. A UAS will be used during surgery, and the size left to the discretion of the surgeon. At the end of the procedure, the urologist will evaluate the ureter for iatrogenic injury, and the ureter will be graded using the Post Ureteroscopic Lesion Scale (PULS). Patients assessed with PULS 0 and PULS 1 will meet 2nd stage eligibility and will be randomized 1:1 to either stent omission or stent placement. When a stent is placed, the stent type and decision to leave a string (tether) will be at the operating urologist's discretion. Hypothesis: \- stent omission arm will be non-inferior to stent placement in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity, and have lower 30-day healthcare utilization.
CONDITIONS
Official Title
Access Sheath and Stent Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available for the study duration
- Planned ureteroscopy using a ureteral access sheath for treatment of unilateral kidney and/or ureteral stones in patients with an existing ureteral stent
- Planned treatment of unilateral renal and/or ureteral stones in a single procedure
- Stones located only in the kidney, only in the ureter, or both
- No significant ureteral injury on intra-operative assessment (PULS Grade 0 or 1)
- Ability and willingness to complete and adhere to survey questions throughout the study
You will not qualify if you...
- Pregnancy
- Ureteric injury during ureteroscopy with PULS Grade 2 or higher
- Evidence of ureteral stricture
- Anatomical abnormalities such as solitary kidney, horseshoe kidney, fused crossed ectopia, pelvic kidney, or urinary diversion
- Planned secondary or staged procedure
- Indwelling nephrostomy tube
- Bilateral ureteroscopy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
M
MUSIC Coordinating Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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