Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

Not Applicable

Completed

• Conditions: Renal Stone; Ureteral Stone

• Registration Number: NCT05026710
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-30
• Study Start: 2021-12-02
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-21
• Results First Submitted: 2025-07-01
• Status Verified: 2025-10
• Results First Submitted QC: 2025-10-13
• Last Update Submitted: 2025-10-13
• Results First Posted: 2025-10-28
• Last Update Posted: 2025-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity 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.	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.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference 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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.
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.	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.
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.	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.
Composite Healthcare Utilization Metric Within 30 Days (WinRatio)	up to 30 days	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
Abnormal Imaging Findings Within 60 Days	up to 60 days	Results reflect the participants whose imaging indicated either new or worsening hydronephrosis in the operative renal unit.
Stone-free Rates Within 60 Days	up to 60 days	Results reflect the participants who had no residual renal stone following treatment based on postoperative imaging.

Trial Locations

Locations (8)

Michigan Medicine; 🇺🇸 Brighton, Michigan, United States

Chelsea Hospital (Saint Joseph Mercy); 🇺🇸 Chelsea, Michigan, United States

Henry Ford Macomb Hospital; 🇺🇸 Clinton Township, Michigan, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Ascension Hospital (Comprehensive Urology); 🇺🇸 Novi, Michigan, United States

William Beaumont Hospital (Michigan Institute of Urology); 🇺🇸 Troy, Michigan, United States

Henry Ford West Bloomfield Hospital; 🇺🇸 West Bloomfield, Michigan, United States

Integrated Healthcare Association (IHA) (Saint Joseph Mercy Hospital); 🇺🇸 Ypsilanti, Michigan, United States