Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) (BLUES)

Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES) A Pragmatic Randomized Multi-center Comparative Effectiveness Study

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.

Study Overview

• Status: Completed
• Conditions: Renal Stone; Ureteral Stone
• Intervention / Treatment: Device: Silicone (Coloplast Imajin Hydro) ureteral stent; Device: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medicine
    • Brighton, Michigan, United States, 48116
      • Michigan Medicine
    • Chelsea, Michigan, United States, 48118
      • Chelsea Hospital (Saint Joseph Mercy)
    • Clinton Township, Michigan, United States, 48038
      • Henry Ford Macomb Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Novi, Michigan, United States, 48374
      • Ascension Hospital (Comprehensive Urology)
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital (Michigan Institute of Urology)
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital (Michigan Institute of Urology)
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford West Bloomfield Hospital
    • Ypsilanti, Michigan, United States, 48197
      • Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silicone (Coloplast Imajin Hydro) ureteral stent	Device: Silicone (Coloplast Imajin Hydro) ureteral stent; During the end of the standard of care ureteroscopy the silicone stent will be placed.
Experimental: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).	Device: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer); During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks	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 4-6 weeks after surgery.	Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks	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 4-6 weeks after surgery.	Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery.
Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days	The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother). Change is defined as the difference in LURN SI-10 total 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 NIH LURN SI-10 Scores at 4 to 6 Weeks	The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms. Responses for each item range from 0 to 4 or 0 to 3 and are then summed for total scores ranging from 0 to 38 (higher scores = worse symptoms/bother). Change is defined as the difference in LURN SI-10 total score from baseline to 4-6 weeks after surgery.	: Baseline, 4 to 6 weeks: Participants can fill out the survey at any time between 4 to 6 weeks after surgery. 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)	WinRatio composite healthcare utilization score ranges from 0 to 5 based on each participants highest level of healthcare utilization, with higher score indicating a worse outcome: 0=no HCU, 1=phone call or EMR message, 2=office visit, 3= Emergency Department visit, 4=Unplanned Hospitalization, 5=Hospitalization with ICU care	up to 30 days
Abnormal Imaging Findings Within 60 Days	Results reflect the participants whose imaging indicated either new or worsening hydronephrosis in the operative renal unit.	up to 60 days
Stone-free Rates Within 60 Days	Results reflect the participants who had no residual renal stone following treatment based on postoperative imaging.	up to 60 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Coloplast A/S
• Investigators: Principal Investigator: Khurshid Ghani, MD, MS, FRCS, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): August 21, 2024

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Lithotripsy; Ureteroscopy; Ureteral stent
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Ureteral Diseases; Nephrolithiasis; Ureterolithiasis
• Other Study ID Numbers: HUM00199486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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