Single Instillation of Hypertonic Saline Immediately Following Transurethral Resection of Bladder Tumor for Recurrence Prevention –A Phase I Study

BACKGROUND: Urologic guidelines recommend perioperative instillation of chemotherapy after transurethral resection bladder tumor (TURBT) to decrease recurrence, yet implementation this recommendation is partial due associated morbidity. Hypertonic saline destroys cells by osmotic dehydration and might present a safer alternative. OBJECTIVE: To evaluate the safety 3% hypertonic (Hypersal) intravesical following TURBT in rats humans. METHODS: In 8 whose bladders were electrically injured, blue-dyed Hypersal was administered. We measured serum sodium levels before pathologically evaluated their pelvic cavity for signs inflammation or blue discoloration. Twenty-four patients recruited human trial (NIH-NCT04147182), 15 comprised interventional 10 control group (one patient crossed over). given postoperatively. Serum before, 1 hour 12–24 hours instillation. Adverse effects documented compared between groups. RESULTS: rats, average 140.0 mEq/L 140.3 instillation, respectively. Necropsy revealed no humans plasma 138.6 mEq∖L, 138.8 mEq∖L 137.7 During postoperative follow-up there one case fever. A month surgery, dysuria reported 5 while urgency hematuria each. The most severe adverse events grade 2 on Clavien-Dindo scale. similar group. CONCLUSIONS: safe tolerable immediately TURBT.