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Novel Antireflux "RELIEF" Stent to Prevent Vesicoureteral Reflux
Michael Callegari1, Anish Patel1, Andrew Drozd1
1Urology Institute, University Hospitals Cleveland Medical Center, Cleveland, OH.
Objective:
To assess efficacy, comfort, and symptoms of a novel ureteral stent (RELIEF) substituting the distal semirigid coil of a traditional double-J for a floating, monofilament tether allowing coaptation of the ureteral orifice. Ureteral instrumentation notoriously cause discomfort, urgency, frequency, dysuria, and hematuria; prolonged morbidity is likely related to stent-associated vesicoureteral reflux (VUR). We hypothesized this design would eliminate VUR, be safe and provide comfort following intervention.
Methods:
Twenty-eight patients within a single institution were enrolled. Passive cystography was performed pre- and post-stent placement assessing VUR. Patients completed Ureteric Stent Symptoms Questionnaires (USSQ) before placement (baseline), postop day 1, and day of removal.
Results:
Twenty RELIEF stents were placed (11 female and 9 male). 95% demonstrated no VUR following placement. No unexpected adverse complications occurred; 1 patient opted for early stent removal for significant discomfort. Average total USSQ scores demonstrated statistically significant improvement between first and third surveys (P < .001). Statistically significant improvement in body pain, general health, and work performance scores were noted as well (P < .05).
Conclusion:
The RELIEF stent eliminates VUR with similar stent-related morbidity and overall well-tolerance. RELIEF-associated USSQ scores were below published mean symptom scores for standard double-J stents and appear safe in this preliminary clinical trial.
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