Better Lithotripsy and Ureteroscopy Evaluation of Stenting (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.

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