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

Stone, Kidney Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866081
• Other study ID #: HUM00234740
• Secondary ID: CER-2021C2-22856
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: University of Michigan
• Contact: Elaina Shoemaker
• Phone: 734-764-3916
• Email: Esekulos[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 792
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Stone Ureter
• Stone, Kidney

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Michigan Health System	Brighton	Michigan
United States	St. Joseph Mercy Health (Trinity)	Chelsea	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Michigan Urological Surgery Improvement Collaborative (MUSIC), Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30		within 30 days after ureteroscopy
Secondary	Number of Participants with Unplanned hospital admission within postoperative day 30		within 30 days after ureteroscopy
Secondary	Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30		within 30 days after ureteroscopy
Secondary	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
Secondary	Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30		within 30 days after ureteroscopy
Secondary	Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30		within 30 days after ureteroscopy
Secondary	PROMIS® Pain Interference (Short Form 6b) change at postoperative 4-6 weeks 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 intensity.	preoperative, 4-6 weeks
Secondary	PROMIS® Pain Intensity (Short Form 3a) change at postoperative day 7-10 preoperative	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.	preoperative, postoperative day 7-10
Secondary	PROMIS® Pain Intensity (Short Form 3a) change at postoperative 4-6 weeks compared to preoperative	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.	preoperative, postoperative 4-6 weeks
Secondary	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	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.	preoperative, postoperative day 7-10
Secondary	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	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.	preoperative, postoperative 4-6 weeks
Secondary	International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at 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.	Postoperative day 7-10
Secondary	International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at 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.	Postoperative 4-6 weeks
Secondary	Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy		First 7 days after ureteroscopy