Actively Recruiting
Access Sheath and Stent Trial Comparing Stent Omission Versus Placement After Ureteroscopy for Kidney and Ureteral Stones
Led by University of Michigan · Updated on 2025-12-22
184
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing patient-reported outcomes for leaving out a stent versus placing a stent after using a ureteral access sheath during uncomplicated ureteroscopy for kidney or ureteral stones. This study evaluates pain interference and intensity as reported by patients, along with healthcare use within 30 days after the procedure. Participants will have a ureteral access sheath used during their ureteroscopy, with the sheath size decided by the surgeon. Ureteral injury will be assessed at the end of surgery using the Post Ureteroscopic Lesion Scale (PULS). Patients with low-grade injury (PULS 0 or 1) will be randomly assigned to either receive a stent or have no stent placed after the procedure. When stents are placed, the type and whether to leave a tether string will be determined by the surgeon. Participants will complete surveys before surgery and at several time points afterward, including daily up to 7-10 days or until stent removal, and again at 30 days. Researchers will collect data on pain, urinary symptoms, social activities, treatment satisfaction, days off work, and healthcare use. Medical records will also be reviewed, and safety and stone clearance will be monitored up to 60 days after the procedure.
CONDITIONS
Brief 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 availability for the study duration
- Planned ureteroscopy using a ureteral access sheath for 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 or only in the ureter, or both renal and ureteral stones
- No significant ureteral injury during surgery (Post-Ureteroscopy Lesion Scale Grade 0 or 1)
- Ability and willingness to complete and respond to survey questions throughout the study
You will not qualify if you...
- Pregnancy
- Ureteric injury during ureteroscopy graded Post-Ureteroscopy Lesion Scale 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
- Presence of an indwelling nephrostomy tube
- Bilateral ureteroscopy planned
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 10 days or until stent removal
Participants undergo a planned ureteroscopy and lithotripsy procedure for kidney and/or ureteral stones with or without stent placement and complete surveys before and after the procedure.
Baseline survey before procedure and daily surveys up to 7-10 days or until stent is removed
Duration - Up to 60 days post-procedure
Participants complete surveys and medical record reviews to assess pain, urinary symptoms, treatment satisfaction, and healthcare utilization after the procedure.
Surveys at 7-10 days, 30 days, and 4-6 weeks after procedure; medical record review within 60 days
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
M
MUSIC Coordinating Center
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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