Access Sheath and Stent Trial for Kidney and Ureteral Stones

This study is looking at how patients feel after surgery for kidney or ureteral stones when a ureteral access sheath (a tube used during surgery) is used. Specifically, it compares patient experiences when a stent (a small tube placed in the ureter) is either left out or put in after the surgery. You might be able to join if you are 18 or older, need ureteroscopy (a procedure to remove stones) for a kidney or ureteral stone, and already have a ureteral stent. The study aims to see if there are differences in your pain levels after the procedure, measured at baseline and again 7-10 days later. The study plans to enroll 184 participants, but its current status is unclear.

Study design: This is an interventional study that plans to enroll 184 participants. After an initial procedure, participants will be randomly assigned to either have a stent placed or not.
What's involved: You will complete surveys before your procedure, daily for up to 7-10 days or until your stent is removed (if placed), and 30 days after the procedure. Your medical records will also be reviewed.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for at least 30 days after the procedure.

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Access Sheath and Stent Trial

Recruiting

NAAges 18+InterventionalHealth services

University of Michigan

~184 participants

Updated 2025-12-22 on ClinicalTrials.gov

What's tested:Surveys

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Differences in PROMIS Pain Interference

Measured over Baseline (before procedure), 7-10 days after procedure

Conditions

Kidney Stone

Ureteral Stone

Where it's being run

1 sites across 1 states

Michigan1

Study leadership

Khurshid Ghani, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

MUSIC Coordinating Center

[email protected]

734-232-4906

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Differences in PROMIS Pain InterferenceBaseline (before procedure), 7-10 days after procedure
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The scores range from 6-30 with a higher score indicating greater interference.

Trialytics