RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)

Quick Facts

Study Start:2023-06-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05866081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently)
  2. * Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan
  3. * Access to means of communication with the study team (email, text messaging, and/or telephone)
  4. * Adequate independent cognitive function and English language proficiency to complete study surveys
  5. * Written informed consent
  1. * Planned bilateral ureteroscopy
  2. * Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney
  3. * Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)
  4. * Anatomic or functional solitary kidney
  5. * Planned secondary or staged ureteroscopy
  6. * Planned use of ureteral access sheath
  7. * Pregnancy
  8. * Patients who use opiate medication daily for greater than 3 months to manage a painful condition

Contacts and Locations

Study Contact

Elaina Shoemaker
CONTACT
734-764-3916
Esekulos@med.umich.edu
Sabrina Clark
CONTACT
734-323-9353
sacl@med.umich.edu

Principal Investigator

Khurshid Ghani, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan Health System
Ann Arbor, Michigan, 48111
United States
University of Michigan Health System
Brighton, Michigan, 48116
United States
St. Joseph Mercy Health (Trinity)
Chelsea, Michigan, 48118
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Khurshid Ghani, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Stone, Kidney
  • Stone Ureter