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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The study intervention is placement of the RELIEF Ureteral Stent
The control product is the Ascerta stent by Boston Scientific.
Retrograde urine reflux
Assessment of retrograde urine reflux after placement of a ureteral stent using cystography after contrast gravity-filling of the bladder and assigning a urinary reflux grade based on standard scoring.
Time frame: At time of stent placement - Day 0, and through study completion - an average of 12 weeks post-operatively
Stent symptoms
Assessment of stent symptoms (incidence, relationship to device, severity) attributed to the ureteral stent; Reporting the Ureteral Stent Symptoms Questionnaire (USSQ) before stent placement, after placement at day 3, prior to removal and post removal; Visualization of distal coil floating in bladder (Y/N) after stent placement
Time frame: Up until stent removal - Day 7-14, and through study completion - and average of 12 weeks post-operatively
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