Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

University of Michigan

Status

Completed

Conditions

Renal Stone

Ureteral Stone

Treatments

Device: Silicone (Coloplast Imajin Hydro) ureteral stent

Device: Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05026710

HUM00199486

Details and patient eligibility

About

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.

Enrollment

224 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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