Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT05866081

Conditions

Stone, Kidney

Stone Ureter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of care stent placement

No stent placement

Surveys

Study Details

Brief summary:

This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent.

Eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission.

Eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants.

The study team hypothesizes that:

  • Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts.
  • Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.

Conditions

Stone, Kidney

Stone Ureter

Study ID

NCT05866081

Start date

Jun 1, 2023

Status verified date

Dec, 2025

Completion date

May 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently)
  • Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan
  • Access to means of communication with the study team (email, text messaging, and/or telephone)
  • Adequate independent cognitive function and English language proficiency to complete study surveys
  • Written informed consent

Exclusion Criteria:

  • Planned bilateral ureteroscopy
  • Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney
  • Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)
  • Anatomic or functional solitary kidney
  • Planned secondary or staged ureteroscopy
  • Planned use of ureteral access sheath
  • Pregnancy
  • Patients who use opiate medication daily for greater than 3 months to manage a painful condition

Second Stage Exclusion Criteria:

  • ureteral perforation
  • unanticipated anatomic abnormality
  • greater than expected bleeding
  • ureteral dilation greater than 12 French
  • ureteral access sheath utilized
  • failed ureteroscopy
  • no or incomplete lithotripsy performed
  • unable to complete case due to medical or anesthetic event.

Study Design

Enrollment

792 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Randomized cohort- No stent placement

Participants that are eligible and consent for the randomization cohort of the trial will not have a stent placed.

If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.

In randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.

experimental: Randomized cohort- Stent placement

Participants that are eligible and consent for the randomization cohort trial will have a stent placed.

If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.

In randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.

other: Observational participants - not randomized

Patients that do not consent to the randomization trial that elect to be on the observational cohort. Stent placement in the observational cohort will be decided by the surgeon intraoperatively, as per routine clinical practice.

Interventions

Standard of care stent placement

Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.

No stent placement

Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.

Surveys

All participants in the trial cohort and observational arms will be asked to complete survey instruments (evaluating their pain, quality of life, and experiences following ureteroscopy, as well as surveys evaluating their opinions and preferences around ureteral stenting, etc.).

Participants will also have routine clinical data (preoperative, perioperative, and postoperative) to be collected and analyzed for research purposes.

Primary outcome measure

  • Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative [ Time Frame: Preoperative, Day 7-10 ]
  • Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Score [ Time Frame: within 30 days after ureteroscopy ]

Central Contacts and Locations

Central contacts

Elaina Shoemaker

734-764-3916Esekulos@med.umich.edu

Sabrina Clark

734-323-9353sacl@med.umich.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Elaina Shoemaker

248-704-9671esekulos@med.umich.edu

Principal Investigator:

David Tzou, MD

UF Health Shands Hospital

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Elaina Shoemaker

734-764-3916esekulos@med.umich.edu

Principal Investigator:

John DiBianco, MD

Indiana University Department of Urology

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Elaina Shoemaker

248-704-9671esekulos@med.umich.edu

Principal Investigator:

Marcelino Rivera, MD

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48111

Contacts

Sabrina Clark

734-323-9353sacl@med.umich.edu

Principal Investigator:

Khurshid Ghani, MD

University of Michigan Health System

Recruiting

Brighton, Michigan, United States, 48116

Contacts

Sabrina Clark

734-323-9353sacl@med.umich.edu

Principal Investigator:

Khurshid Ghani, MD

Cadillac Munson Hospital

Recruiting

Cadillac, Michigan, United States, 49601

Contacts

Elaina Shoemaker

734-764-3916esekulos@med.umich.edu

Principal Investigator:

Laris Galejs, MD

St. Joseph Health System Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Elaina Shoemaker

248-704-9671esekulos@med.umich.edu

Principal Investigator:

Andre King, MD

St. Joseph Mercy Health (Trinity)

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Sabrina Clark

734-323-9353sacl@med.umich.edu

Casey Dauw, MD

734-936-7030caseydau@med.umich.edu

Principal Investigator:

Casey Dauw, MD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Elaina Shoemaker

248-704-9671esekulos@med.umich.edu

Principal Investigator:

David Leavitt, MD

Corewell Health Buttersworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Elaina Shoemaker

734-764-3916esekulos@med.umich.edu

Principal Investigator:

Russell Becker, MD

E.W Sparrow Hospital

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Elaina Shoemaker

734-764-3916esekulos@med.umich.edu

Principal Investigator:

Richard Sarle, MD

MyMichigan Medical Center Midland

Recruiting

Midland, Michigan, United States, 48670

Contacts

Elaina Shoemaker

736-764-3916esekulos@med.umich.edu

Principal Investigator:

Karla Witzke, MD

Michigan Institute of Urology Town Center Ambulatory Surgery Center

Recruiting

Troy, Michigan, United States, 48084

Contacts

Elaina Shoemaker

734-764-3916esekulos@med.umich.edu

Principal Investigator:

Jason Hafron, MD

Monte Fiore

Recruiting

Brooklyn, New York, United States, 10467

Contacts

Elaina Shoemaker

734-764-3916esekulos@med.umich.edu

Principal Investigator:

Dima Raskolnikov, MD

Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Elaina Shoemaker

734-764-3916esekulos@med.umich.edu

Blair Gallante

631-991-1159blair.gallante@mountsinai.org

Principal Investigator:

Mantu Gupta, MD

UNC Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Elaina Shoemaker

734-764-3916esekulos@med.umich.edu

Principal Investigator:

David Friedlander, MD

More Information

Sponsor

University of Michigan

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Unilateral ureteroscopy and lithotripsy
  • Ureteral stent
  • Pain assessment
  • 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 2025-12-15.