N/A N=219 Randomized Treatment

Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

Renal Stone · Ureteral Stone

Bottom Line

View on ClinicalTrials.gov: NCT05026710 ↗

Enrolled (actual)

219

Serious AEs

2.3%

Results posted

Oct 2025

Primary outcome: Primary: Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days — 4.28; 2.92 T-score — p=0.26

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Silicone (Coloplast Imajin Hydro) ureteral stent (Device); Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 7 to 10 Days	4.28; 2.92	0.26
PRIMARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 7 to 10 Days	4.62; 3.24	0.57
SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-intensity at 4 to 6 Weeks	-6.60; -9.93	0.58
SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Scores of Pain-interference at 4 to 6 Weeks	-6.38; -8.08	0.72
SECONDARY Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 Scores at 7 to 10 Days	2.53; 2.90	0.50
SECONDARY Change in NIH LURN SI-10 Scores at 4 to 6 Weeks	-2.54; -3.23	0.80
SECONDARY Composite Healthcare Utilization Metric Within 30 Days (WinRatio)	0; 0	0.25
SECONDARY Abnormal Imaging Findings Within 60 Days	7; 6	0.44
SECONDARY Stone-free Rates Within 60 Days	33; 32	0.85

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05026710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.