Recruiting

Stent Omission vs. Placement

Sponsor:

University of Michigan

Code:

NCT07297953

Conditions

Kidney Stone

Ureteral Stone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surveys

Study Details

Brief summary:

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

Kidney Stone

Ureteral Stone

Study ID

NCT07297953

Start date

Sep 24, 2025

Status verified date

Dec, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Stent omission arm

Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.

other: Stent placement arm

Participants will complete surveys before and after a planned ureteroscopy and lithotripsy for stone disease.

Interventions

Surveys

Surveys will be completed for each group at the following timeframes: baseline (pre-procedure, daily up to 7-10 days or until stent is removed (if placed), 30 days after the procedure. Additionally, participants medical records will reviewed for information.

Primary outcome measure

  • Differences in PROMIS Pain Interference [ Time Frame: Baseline (before procedure), 7-10 days after procedure ]

Central Contacts and Locations

Central contacts

MUSIC Coordinating Center

734-232-4906esekulos@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Elaina Shoemaker

734-232-4906esekulos@med.umich.edu

Principal Investigator:

Kurshid Ghani, MS, FRCS

More Information

Sponsor

University of Michigan

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

  • Ureteral stent
  • Ureteroscopy and lithotripsy
  • Surveys
  • Quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-12-22.