Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)
BLUES
1 other identifier
interventional
224
1 country
10
Brief Summary
This multi-center trial is being completed to compare patient outcomes related to the Imajin silicone stent in comparison to non-silicone polyurethane stents after ureteroscopy. Eligible participants will be enrolled and randomly assigned to receive the Imajin silicone stent or a non-silicone stent. In addition, the participants will complete questionnaires and have follow-up information collected (approximately 60 days after surgery). The trial hypothesizes that a ureteral stent made of silicone, will have superior outcomes when compared to non-silicone stents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedStudy Start
First participant enrolled
December 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2024
CompletedResults Posted
Study results publicly available
October 28, 2025
CompletedOctober 28, 2025
October 1, 2025
2.6 years
August 23, 2021
July 1, 2025
October 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days
This is a 3-item survey which participants select a response for each item from 1=no pain to 5=very severe for intensity of their pain. The sum of responses is then converted into a T-score that ranges from 36.3 to 81.8, with higher scores indicating worse pain intensity. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.
Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days
This is a 6-item survey which participants select a response for each item from 1=not at all to 5=very much for how much pain interfered with their life. The sum of responses is then converted into a T-score that ranges from 41.0 to 78.3, with higher scores indicating worse pain interference. Change is defined as the difference in T-score from baseline to 7-10 days after surgery.
Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
Secondary Outcomes (7)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks
Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks
Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days
Baseline, 7 to 10 days: Participants can fill out the survey at any time between 7 to 10 days after surgery.
Change in NIH LURN SI-10 Scores at 4 to 6 Weeks
: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Composite Healthcare Utilization Metric Within 30 Days (WinRatio)
up to 30 days
- +2 more secondary outcomes
Study Arms (2)
Silicone (Coloplast Imajin Hydro) ureteral stent
EXPERIMENTALNon-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).
EXPERIMENTALInterventions
During the end of the standard of care ureteroscopy the silicone stent will be placed.
During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
Eligibility Criteria
You may qualify if:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with unilateral renal and/or ureteral stones with the largest less than or equal to (≤)2.0 cm in size measured on abdominal x-ray, Ultrasound or computerized tomography (CT) scan
- Renal stone defined as only renal location of stone(s).
- Ureteral stone defined as ureteral only or ureteral and renal stone(s).
- Planned unilateral ureteroscopy with stent placement without stent string.
- Ability to take oral medication.
- Ability and willingness to complete and adhere to survey questions and responses throughout study duration.
You may not qualify if:
- Known planned secondary or staged procedure
- Presence of anatomical anomalies (for example (e.g.) solitary, horseshoe, fused crossed ectopia, pelvic kidney)
- Presence of any prior urinary diversion (e.g. ileal conduit, orthotopic neobladder)
- Presence of any indwelling ureteral stent prior to ureteroscopy
- Presence of any indwelling nephrostomy tube prior to ureteroscopy
- Ancillary ureteroscopy to treat residual fragments after percutaneous renal stone surgery
- Renal stone located in calyceal diverticulum
- No indication for stent placement (e.g. spontaneous passage)
- Bladder stone location.
- Pregnancy or lactation
- Known allergic reactions to polyurethane or silicone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Coloplast A/Scollaborator
Study Sites (10)
Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Michigan Medicine
Brighton, Michigan, 48116, United States
Chelsea Hospital (Saint Joseph Mercy)
Chelsea, Michigan, 48118, United States
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Ascension Hospital (Comprehensive Urology)
Novi, Michigan, 48374, United States
William Beaumont Hospital (Michigan Institute of Urology)
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital (Michigan Institute of Urology)
Troy, Michigan, 48085, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital)
Ypsilanti, Michigan, 48197, United States
Related Publications (1)
Becker REN, DiBianco JM, Higgins AM, Konheim J, Kleer E, Leavitt D, King A, Kachroo N, Majdalany SE, Gandham D, Fernandez Moncaleano G, Conrado B, Shoemaker E, Daignault-Newton S, Dauw CA, Ghani KR. Daily Ecological Momentary Assessments of Pain and Ability to Work After Ureteroscopy and Stenting. J Endourol. 2024 Jun;38(6):545-551. doi: 10.1089/end.2023.0625.
PMID: 38545762DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Khurshid Ghani, MD
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Khurshid Ghani, MD, MS, FRCS
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Urology
Study Record Dates
First Submitted
August 23, 2021
First Posted
August 30, 2021
Study Start
December 2, 2021
Primary Completion
July 1, 2024
Study Completion
August 21, 2024
Last Updated
October 28, 2025
Results First Posted
October 28, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share