Back to resultsStent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Primary Purpose
Stone, Kidney, Stone Ureter
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of care stent placement
No stent placement
Surveys
Sponsored by
About this trial
This is an interventional treatment trial for Stone, Kidney focused on measuring Unilateral ureteroscopy and lithotripsy, Ureteral stent, Pain assessment, Quality of life
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.
Sites / Locations
- University of Michigan Health SystemRecruiting
- University of Michigan Health SystemRecruiting
- St. Joseph Mercy Health (Trinity)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Other
Arm Label
Randomized cohort- No stent placement
Randomized cohort- Stent placement
Observational participants - not randomized
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30
Number of Participants with Unplanned hospital admission within postoperative day 30
Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30
Number of Participants with Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30
Unplanned ambulatory urology office visit and/or diagnostic testing (urine testing and/or imaging) within postoperative day 30
Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30
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.
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.
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.
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.
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.
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.
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.
Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy
Full Information
NCT ID
NCT05866081
First Posted
April 24, 2023
Last Updated
July 28, 2023
Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute, Michigan Urological Surgery Improvement Collaborative (MUSIC)
1. Study Identification
Unique Protocol Identification Number
NCT05866081
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute, Michigan Urological Surgery Improvement Collaborative (MUSIC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone, Kidney, Stone Ureter
Keywords
Unilateral ureteroscopy and lithotripsy, Ureteral stent, Pain assessment, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care Provider
Masking Description
Surgeons will remain blinded to this allocation until the surgeon has confirmed secondary eligibility.
Allocation
Randomized
Enrollment
792 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Randomized cohort- No stent placement
Arm Type
Other
Arm Description
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.
Arm Title
Randomized cohort- Stent placement
Arm Type
Experimental
Arm Description
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.
Arm Title
Observational participants - not randomized
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard of care stent placement
Intervention Description
Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
Intervention Type
Other
Intervention Name(s)
No stent placement
Intervention Description
Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.
Intervention Type
Other
Intervention Name(s)
Surveys
Intervention Description
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 Outcome Measure Information:
Title
Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative
Description
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.
Time Frame
Preoperative, Day 7-10
Title
Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Score
Description
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
Time Frame
within 30 days after ureteroscopy
Secondary Outcome Measure Information:
Title
Number of Participants with Intensive Care Unit care during unplanned hospital admission within postoperative day 30
Time Frame
within 30 days after ureteroscopy
Title
Number of Participants with Unplanned hospital admission within postoperative day 30
Time Frame
within 30 days after ureteroscopy
Title
Number of Participants with Unplanned additional procedure related to ureteroscopy within postoperative day 30
Time Frame
within 30 days after ureteroscopy
Title
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
Title
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
Title
Number of ambulatory patient-provider interactions: phone calls / EMR messages within postoperative day 30
Time Frame
within 30 days after ureteroscopy
Title
PROMIS® Pain Interference (Short Form 6b) change at postoperative 4-6 weeks compared to preoperative
Description
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.
Time Frame
preoperative, 4-6 weeks
Title
PROMIS® Pain Intensity (Short Form 3a) change at postoperative day 7-10 preoperative
Description
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.
Time Frame
preoperative, postoperative day 7-10
Title
PROMIS® Pain Intensity (Short Form 3a) change at postoperative 4-6 weeks compared to preoperative
Description
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.
Time Frame
preoperative, postoperative 4-6 weeks
Title
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
Description
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.
Time Frame
preoperative, postoperative day 7-10
Title
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
Description
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.
Time Frame
preoperative, postoperative 4-6 weeks
Title
International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative day 7-10
Description
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.
Time Frame
Postoperative day 7-10
Title
International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative 4-6 weeks
Description
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.
Time Frame
Postoperative 4-6 weeks
Title
Number of days taken off work by patients and caregivers during the first 7 days after ureteroscopy
Time Frame
First 7 days after ureteroscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaina Shoemaker
Phone
734-764-3916
Email
Esekulos@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Clark
Phone
734-323-9353
Email
sacl@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khurshid Ghani, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Clark
Phone
734-323-9353
Email
sacl@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Khurshid Ghani, MD
Facility Name
University of Michigan Health System
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Clark
Phone
734-323-9353
Email
sacl@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Khurshid Ghani, MD
Facility Name
St. Joseph Mercy Health (Trinity)
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Clark
Phone
734-323-9353
Email
sacl@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Casey Dauw, MD
Phone
734-936-7030
Email
caseydau@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Casey Dauw, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
We'll reach out to this number within 24 hrs