Kidney Stone
Conditions
Keywords
ureteral stent
Brief summary
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).
Interventions
DEVICERELIEF Ureteral Stent
The study intervention is placement of the RELIEF Ureteral Stent
DEVICEStandard of Care Ureteral Stent
The control product is the Ascerta stent by Boston Scientific.
Sponsors
University of California, San Diego
The Ureteral Stent Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retrograde urine reflux | At time of stent placement - Day 0, and through study completion - an average of 12 weeks post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent symptoms | Up until stent removal - Day 7-14, and through study completion - and average of 12 weeks post-operatively | 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 |
Contacts
PRINCIPAL_INVESTIGATORSeth K Bechis, MD
University of California, San Diego
Outcome results
None listed