Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative

NCT05866081 | Recruiting DMC FDA Device

• 2 other identifiers: HUM00234740CER-2021C2-22856
• Study Type: interventional
• Target: 792
• Locations: 1 country
• Sites: 16

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

Keywords

Unilateral ureteroscopy and lithotripsy; Ureteral stent; Pain assessment; Quality of life

Outcome Measures

Primary Outcomes (2)

• Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative

  This survey has 6 questions that participants select from 1(not at all) to 5 (very much) for questions 1-5 related to pain interference. For question 6 participants select from 1 (Never) to 5 (Always). There are total of 6-30 points where the higher the score the more pain interference.

  Preoperative, Day 7-10

• Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Score

  Compare within each cohort each No Stent Placement patient head-to-head against each Stent Placement patient using a hierarchical composite comprised of: * Intensive care unit (ICU) care during hospitalization * Unplanned hospitalization * Unplanned additional procedure related to ureteroscopy: operating room or interventional radiology procedure * Emergency department visit * Unplanned clinic visit and/or diagnostic testing (blood, urine testing and/or imaging) * Number of ambulatory patient-provider interactions: phone calls / Electronic Medical Record (EMR) messages

  within 30 days after ureteroscopy

Secondary Outcomes (14)

• Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30

  within 30 days after ureteroscopy

• Number of Participants with Unplanned hospital admission within postoperative day 30

  within 30 days after ureteroscopy

• Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30

  within 30 days after ureteroscopy

• Number of Participants with Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30

  within 30 days after ureteroscopy

• Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30

  within 30 days after ureteroscopy

Study Arms (3)

Randomized cohort- No stent placement

OTHER

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.

Other: No stent placement; Other: Surveys

Randomized cohort- Stent placement

EXPERIMENTAL

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.

Device: Standard of care stent placement; Other: Surveys

Observational participants - not randomized

OTHER

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.

Other: Surveys

Interventions

Surveys OTHER

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.

Observational participants - not randomized; Randomized cohort- No stent placement; Randomized cohort- Stent placement

Standard of care stent placement DEVICE

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

Randomized cohort- Stent placement

No stent placement OTHER

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

Randomized cohort- No stent placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Michigan Urological Surgery Improvement Collaborative (MUSIC): collaborator
• University of Michigan: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (16)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

UF Health Shands Hospital

Gainesville, Florida, 32608, United States

RECRUITING

Indiana University Department of Urology

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Michigan Health System

Ann Arbor, Michigan, 48111, United States

RECRUITING

University of Michigan Health System

Brighton, Michigan, 48116, United States

RECRUITING

Cadillac Munson Hospital

Cadillac, Michigan, 49601, United States

RECRUITING

St. Joseph Health System Chelsea Hospital

Chelsea, Michigan, 48118, United States

RECRUITING

St. Joseph Mercy Health (Trinity)

Chelsea, Michigan, 48118, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Corewell Health Buttersworth Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

E.W Sparrow Hospital

Lansing, Michigan, 48912, United States

RECRUITING

MyMichigan Medical Center Midland

Midland, Michigan, 48670, United States

RECRUITING

Michigan Institute of Urology Town Center Ambulatory Surgery Center

Troy, Michigan, 48084, United States

RECRUITING

Monte Fiore

Brooklyn, New York, 10467, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

UNC Hospital

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Related Publications (1)

• Becker REN, Daignault-Newton S, Shoemaker E, Sitek D, Thelus JM, Clark S, Martin-Schwarze A, Spino C, Carlozzi NE, Meurer WJ, Sales AE, Dauw CA, Ghani KR. Stent Omission after Ureteroscopy and Lithotripsy (SOUL) in the Michigan Urological Surgery Improvement Collaborative (MUSIC): study protocol for a pragmatic prospective combined randomized and observational clinical trial. Trials. 2024 Dec 4;25(1):811. doi: 10.1186/s13063-024-08587-8.

  PMID: 39633425 DERIVED

MeSH Terms

Conditions

Kidney Calculi; Ureterolithiasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Khurshid Ghani, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaina Shoemaker

CONTACT

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

Sabrina Clark

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Surgeons will remain blinded to this allocation until the surgeon has confirmed secondary eligibility.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Model Details: Participants that consent for the randomization cohort (264 anticipated) will be randomized using an online computer-based system to either stent omission or stent placement in a 1:1 ratio following secondary eligibility criteria. Blocked, stratified randomization based upon surgeon classified stone location (renal only versus ureteral with or without renal), with random block sizes will be used to ensure group balance. Observational study participants (528 anticipated) will not be randomized.

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 19, 2023
• Study Start: June 1, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)