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NCT Number: NCT05866081

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona, Tucson, Arizona, United States

Loading trial locations.

About this study

The coordinating center for this study is the Michigan Urological Surgery Improvement Collaborative (MUSIC), which is a physician-led Quality Improvement (QI) collaborative comprised of 44 urology practices and 260 urologists across the State of Michigan.

As sites are activated the registration will be updated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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

    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.

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

    Time frame: within 30 days after ureteroscopy

    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

Secondary outcomes

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

    Time frame: within 30 days after ureteroscopy

  2. Number of Participants with Unplanned hospital admission within postoperative day 30

    Time frame: within 30 days after ureteroscopy

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

    Time frame: within 30 days after ureteroscopy

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

    Time frame: within 30 days after ureteroscopy

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

    Time frame: within 30 days after ureteroscopy

  6. Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30

    Time frame: within 30 days after ureteroscopy

  7. PROMIS® Pain Interference (Short Form 6b) change at postoperative 4-6 weeks compared to preoperative

    Time frame: preoperative, 4-6 weeks

    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 intensity.

  8. PROMIS® Pain Intensity (Short Form 3a) change at postoperative day 7-10 preoperative

    Time frame: preoperative, postoperative day 7-10

    This is a 3-question survey that participants select from 1 (had no pain) to 5 (very severe) for the first 2 questions. For the third question participants select how level of pain is now 1 (no pain) to 5 (very severe). There are total of 3-15 points where the higher the score the more pain intensity.

  9. PROMIS® Pain Intensity (Short Form 3a) change at postoperative 4-6 weeks compared to preoperative

    Time frame: preoperative, postoperative 4-6 weeks

    This is a 3-question survey that participants select from 1 (had no pain) to 5 (very severe) for the first 2 questions. For the third question participants select how level of pain is now 1 (no pain) to 5 (very severe). There are total of 3-15 points where the higher the score the more pain interference.

  10. National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative day 7-10 compared to preoperative

    Time frame: preoperative, postoperative day 7-10

    The is 10-Item index that assesses participants urinary symptoms. For questions 1-8 Participants select from 0 (never)-4 every time. For questions 9 and 10 participants select from 0 (none) -3 (more than 3 times). There are total of 0-38 points where the higher the score the more pain symptoms.

  11. National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative 4-6 weeks compared to preoperative

    Time frame: preoperative, postoperative 4-6 weeks

    The is 10-Item index that assesses participants urinary symptoms. For questions 1-8 Participants select from 0 (never)-4 every time. For questions 9 and 10 participants select from 0 (none) -3 (more than 3 times). There are total of 0-38 points where the higher the score the more pain intensity.

  12. International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative day 7-10

    Time frame: Postoperative day 7-10

    Participants will complete this 14-question survey regarding satisfaction of treatment.

    The ICIQ-S assesses aspects of experience, expectations, and outcomes to evaluate satisfaction after urological surgery. A scoring system has been derived that consists of two parts: a score for the evaluation of satisfaction with 'surgical outcomes' (ICIQ-S outcome score, range 0-24); and the overall satisfaction with surgery item, scored 0-10. Higher scores indicate more satisfaction.

  13. International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative 4-6 weeks

    Time frame: Postoperative 4-6 weeks

    Participants will complete this 14-question survey regarding satisfaction of treatment.

    The ICIQ-S assesses aspects of experience, expectations, and outcomes to evaluate satisfaction after urological surgery. A scoring system has been derived that consists of two parts: a score for the evaluation of satisfaction with 'surgical outcomes' (ICIQ-S outcome score, range 0-24); and the overall satisfaction with surgery item, scored 0-10. Higher scores indicate more satisfaction.

  14. Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy

    Time frame: First 7 days after ureteroscopy

Study contacts

Contact information is provided by the study sponsor or research team.

Elaina Shoemaker

CONTACT

[email protected]

734-764-3916

Sabrina Clark

CONTACT

[email protected]

734-323-9353

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Michigan Urological Surgery Improvement Collaborative (MUSIC)
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 19, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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