The RELIEF™ Ureteral Stent Randomized Controlled Trial

The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux

Assessment of the backwards flow of urine from the bladder into the ureter (retrograde urine reflux) after placement of the RELIEF® Ureteral Stent using imaging of the bladder after filling it with contrast and assigning a urinary reflux grade. Randomized controlled trial for evaluation of the stent placement and the adequacy of short term drainage (defined as the presence of the stent in the ureter and the lack of surgical or standard of care double J stent to treat symptoms associated with the stent itself on the stented side during the first 48 hours).

Inclusion Criteria:

• Has capacity to consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Persons, 18 years of age or older
• Male or female subjects with confirmed ureteral and/or renal stones or strictures documented via abdomen X-ray KUB (kidney ureter bladder) or CT (computed tomography)

Exclusion Criteria:

• Distal ureteral obstruction where suture portion of stent may be placed
• Urinary reflux (assessed by pre-stent cystogram)
• Pregnancy or lactation
• Patients requiring bilateral surgical stone management procedure
• Infected stones
• Patients where 24cm or 26cm stent lengths are not suitable
• Ureteral structure in distal third of ureter
• Intraoperative exclusion: based on urologist's discretion, if trauma has been induced to the distal ureter due to ureteroscopy maneuvers, exclude these patients