The goal of this study was to clinically validate the utility of a commercially viable disruptive medical technology for use during space exploration. Application to date has been on expelling stones from the kidney. This work will expand the capabilities of the technology to meet the more advanced needs in space. The investigators conducted an analog test of a new way to save astronauts from the debilitating pain of kidney stones where there currently are no treatment options. They validated, in emergency department patients, the capability to dislodge and reposition ureteral stones in two locations: the uretero-pelvic junction (UPJ) from obstructing and/or the uretero- vesical junction (UVJ). The technology will work as an adjunct to medications and other interventions used to try to prevent stone formation, ease stone passage, or mitigate pain. The capability has already been built into NASA's Flexible Ultrasound System (FUS) and as such the complexity and cost of including such a potentially game changing technology for astronaut safety is extremely low.
The experiment had the following specific aim:
Participants immediately underwent a brief ultrasound exam with the investigative device to confirm the location of the stone and extent of hydronephrosis after treatment. Participants will complete a final pain questionnaire addressing any discomfort or pain they may have felt related to the procedure. The subject will be provided with a strainer to collect stones during the three-week verbal follow-up period. The subject was provided with a medical diary sheet to record their medication use during the three-week verbal follow-up period. Subjects will return after four to six weeks for clinical imaging with either low dose CT or KUB/ultrasound, similar to standard of care for urologic stenting or shock wave lithotripsy. The electronic health record (EHR) was reviewed for 90 days to assess for return visits to the ED, surgery, and/or additional imaging.
For the three UPJ cases, stone motion was observed in 1 of 3 subjects. None of the subjects reported a decrease in pain level and no decrease in hydronephrosis was observed pre- to post-procedure. For the distal ureter cases, some level of stone motion was observed in approximately 50% of the cases. Seventeen of 20 subjects with at least 2 weeks of follow-up data passed their stones an average of 4.2 ± 5.0 days post-procedure. Five subjects reported passing their stone within 24 hours of the investigational procedure. Three of the remaining five distal ureter cases continued on for standard-of-care surgical intervention for their stone; the remaining two subjects have not reported passing a stone or completed follow-up imaging.
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