ArticleBladder cancer (Amsterdam, Netherlands)2021
Single Instillation of Hypertonic Saline Immediately Following Transurethral Resection of Bladder Tumor for Recurrence Prevention -A Phase I Study.
Article in Bladder cancer (Amsterdam, Netherlands), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04147182 (Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder), which is not on this map. Not yet cited in PubMed.
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Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder
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14 authors.
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Abstract
backgroundUrologic guidelines recommend perioperative instillation of chemotherapy after transurethral resection of bladder tumor (TURBT) to decrease tumor recurrence, yet implementation of this recommendation is partial due to associated morbidity. Hypertonic saline destroys cells by osmotic dehydration and might present a safer alternative.
objectiveTo evaluate the safety of 3% hypertonic saline (Hypersal) intravesical instillation following TURBT in rats and in humans.
methodsIn 8 rats whose bladders were electrically injured, intravesical blue-dyed Hypersal was administered. We measured serum sodium levels before and after instillation and pathologically evaluated their pelvic cavity for signs of inflammation or blue discoloration. Twenty-four patients were recruited to the human trial (NIH-NCT04147182), 15 comprised the interventional and 10 the control group (one patient crossed over). Hypersal was given postoperatively. Serum sodium was measured before, 1 hour and 12-24 hours after instillation. Adverse effects were documented and compared between the groups.
resultsIn rats, average sodium levels were 140.0 mEq/L and 140.3 mEq/L before and following instillation, respectively. Necropsy revealed no signs of inflammation or blue discoloration. In humans the average plasma sodium levels were 138.6 mEq∖L, 138.8 mEq∖L and 137.7 mEq∖L before, 1 hour and 12-24 hours after instillation, respectively. During the postoperative follow-up there was one case of fever. A month after the surgery, dysuria was reported by 5 patients while urgency and hematuria were reported by one patient each. The most severe adverse events were grade 2 on the Clavien-Dindo scale. Adverse events were similar in the control group.
conclusionsHypersal instillation is safe and tolerable immediately after TURBT.
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