The RELIEF™ Ureteral Stent - Assessment of Retrograde Urinary Reflux
Overview
- Phase
- Not Applicable
- Intervention
- Standard of Care Ureteral Stent
- Conditions
- Kidney Stone
- Sponsor
- University of California, San Diego
- Enrollment
- 50
- Primary Endpoint
- Retrograde urine reflux
- Status
- Withdrawn
- Last Updated
- 2 months ago
Overview
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).
Investigators
Seth Bechis
Associate Professor of Urology
University of California, San Diego
Eligibility Criteria
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
Arms & Interventions
Standard of Care Ureteral Stent
Intervention: Standard of Care Ureteral Stent
RELIEF Ureteral Stent
Intervention: RELIEF Ureteral Stent
Outcomes
Primary Outcomes
Retrograde urine reflux
Time Frame: 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 Outcomes
- Stent symptoms(Up until stent removal - Day 7-14, and through study completion - and average of 12 weeks post-operatively)