Clinical trial NCT05866081: Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Official title: Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stone, Kidney
Stone Ureter
Keywords: Unilateral ureteroscopy and lithotripsy
Ureteral stent
Pain assessment
Quality of life
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Michigan Urological Surgery Improvement Collaborative (MUSIC)
First posted: 2023-05-19
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative
timeFrame: Preoperative, Day 7-10
measure: Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Score
timeFrame: within 30 days after ureteroscopy
Secondary outcomes:
measure: Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30
timeFrame: within 30 days after ureteroscopy
measure: Number of Participants with Unplanned hospital admission within postoperative day 30
timeFrame: within 30 days after ureteroscopy
measure: Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30
timeFrame: within 30 days after ureteroscopy
measure: Number of Participants with Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30
timeFrame: within 30 days after ureteroscopy
measure: Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30
timeFrame: within 30 days after ureteroscopy
measure: Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30
timeFrame: within 30 days after ureteroscopy
measure: PROMIS® Pain Interference (Short Form 6b) change at postoperative 4-6 weeks compared to preoperative
timeFrame: preoperative, 4-6 weeks
measure: PROMIS® Pain Intensity (Short Form 3a) change at postoperative day 7-10 preoperative
timeFrame: preoperative, postoperative day 7-10
measure: PROMIS® Pain Intensity (Short Form 3a) change at postoperative 4-6 weeks compared to preoperative
timeFrame: preoperative, postoperative 4-6 weeks
measure: 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
timeFrame: preoperative, postoperative day 7-10
measure: 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
timeFrame: preoperative, postoperative 4-6 weeks
measure: International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative day 7-10
timeFrame: Postoperative day 7-10
measure: International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative 4-6 weeks
timeFrame: Postoperative 4-6 weeks
measure: Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy
timeFrame: First 7 days after ureteroscopy
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Shands Hospital
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Brighton
country: United States
facility: University of Michigan Health System
state: Michigan
city: Cadillac
country: United States
facility: Cadillac Munson Hospital
state: Michigan
city: Chelsea
country: United States
facility: St. Joseph Health System Chelsea Hospital
state: Michigan
city: Chelsea
country: United States
facility: St. Joseph Mercy Health (Trinity)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health Buttersworth Hospital
state: Michigan
city: Lansing
country: United States
facility: E.W Sparrow Hospital
state: Michigan
city: Midland
country: United States
facility: MyMichigan Medical Center Midland
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology Town Center Ambulatory Surgery Center
state: Michigan
city: Brooklyn
country: United States
facility: Monte Fiore
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospital
state: North Carolina
Study officials:
affiliation: University of Michigan
name: Khurshid Ghani, MD
role: PRINCIPAL_INVESTIGATOR
References: