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Project Title:  Renal Stone Ureter Management Technology Development and Clinical Validation Study Reduce
Images: icon  Fiscal Year: FY 2020 
Division: Human Research 
Research Discipline/Element:
ExMC:Exploration Medical Capabilities 
Start Date: 04/02/2018  
End Date: 04/23/2022  
Task Last Updated: 02/20/2020 
Download report in PDF pdf
Principal Investigator/Affiliation:   Hall, M. Kennedy  M.D. / University of Washington 
Address:  Dept. of Emergency Medicine 
 
Seattle , WA 98195 
Email: mkhall@uw.edu 
Phone: 206-744-8469  
Congressional District:
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Washington 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Wessells, Hunter  M.D. University of Washington 
Bailey, Michael  Ph.D. University of Washington 
Project Information: Grant/Contract No. Directed Research 
Responsible Center: NASA JSC 
Grant Monitor: Lehnhardt, Kris  
Center Contact: 281.244.0524 
kris.lehnhardt@nasa.gov 
Solicitation: Directed Research 
Grant/Contract No.: Directed Research 
Project Type: GROUND 
Flight Program:  
TechPort: No 
No. of Post Docs:
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) ExMC:Exploration Medical Capabilities
Human Research Program Risks: (1) Medical:Risk of Adverse Health Outcomes & Decrements in Performance due to Inflight Medical Conditions (IRP Rev I)
 (2) Renal:Risk of Renal Stone Formation
Human Research Program Gaps: (1) Med12:We do not have the capability to mitigate select medical conditions (IRP Rev I)
Flight Assignment/Project Notes: NOTE: Start date changed to 4/02/2018 (from 4/24/2019) per K. Lehnhardt/ExMC element scientist (Ed., 2/19/2020)

Task Description: Kidney stones have long been near the top of NASA’s list of medical concerns. With this proposal we are addressing the following gaps from NASA's Human Research Roadmap ( https://humanresearchroadmap.nasa.gov ): Med 12 We do not have the capability to mitigate select medical conditions and Med 13 We do not have the capability to implement medical resources that enhance operational innovation for medical needs. Med 12 and 13 "will: 'Develop the capability to diagnose or treat renal stones in an exploration missions.' and 'Develop the relevant medical capabilities to technical maturity." The risk is that a stone, while innocuous when still in the kidney, will cause debilitating pain as it passes or worse, become obstructing, which can lead to urinary tract infection, sepsis, renal failure, and death. We propose a clinical trial of a countermeasure for this urgent condition which we have developed together with NASA.

Stones have plagued humans since ancient Egypt. One in eleven Americans has suffered from stones -- more than have diabetes or cardiovascular disease. Dehydration, stasis, and bone demineralization are strong contributors to kidney stones, and occur in microgravity, increasing the risk of stones in space. Stones are often debilitating, and pilots cannot fly with stones. Science, experience, and the negative medical consequences support concern for the risk of stones in space. NASA has focused considerable attention on stone mitigation and made progress. However, there are many types of stone disease, and it is unlikely that stone disease will ever be completely prevented on Earth or in space.

The impact of this project will be 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. The proposed work will expand the capabilities of the technology to meet the more advanced needs in space.

Rationale for HRP Directed Research: This research is directed because it contains highly constrained research. Due to weightlessness in space, it is believed that astronauts have a higher than normal probability to develop kidney stones. Novel, unique ultrasound technology developed by the University of Washington has been demonstrated to identify and move small renal stones within the kidneys. The next challenge with kidney stones is that they can block the ureteropelvic junction (UPJ) and ureterovesical junction (UVJ) positions of the ureter. This study will demonstrate that the ultrasound technology developed by the University of Washington can move renal stones blocking the UPJ and UVJ junctions thus relieving pain associated with hydronephrosis.

Research Impact/Earth Benefits: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) writes (1) “Urinary Stone Disease (USD) is an important health care problem affecting both adults and children, causing pain and suffering for the patient and a financial burden to the Nation. One in 11 Americans now has USD, and the prevalence is increasing (2). According to the NIDDK-funded study, the direct medical cost of USD in the United States is $10 billion annually, making it the most expensive urologic condition (3).”

While stones are innocuous in the kidney, obstruction, which occurs when a stone impedes urine flow through the ureter and causes a buildup of pressure in the kidney, is the dominant cause to seek medical attention for stones (4-7). Obstruction leads to severe pain and significant risk (sepsis, kidney loss, death); therefore, relief of obstruction is the primary reason for intervention, hospitalization, imaging, and healthcare expense (4-7). Annually, stone obstruction of the ureter, predominantly at the ureteropelvic (UPJ) and the ureterovesical junction, which are visible locations on ultrasound, results in greater than 1,000,000 annual visits to U.S. emergency departments (ED) (7). There is no simple management solution for obstruction in the acute setting; the physician primarily manages pain and mitigates risks due to obstruction. From a recent urologic textbook: “Stone treatments may not be performed in the acute setting secondary to patient factors (active infection, renal failure, ureteral inflammation/edema) and hospital system factors (operating room, special equipment, and staff availability).” (5) Medical expulsive therapy may be prescribed to facilitate passage, and the patients are discharged to wait and see if the stone will pass. Stone passage from the UVJ takes up to 4 weeks, and frequently includes additional ED visits for pain (8). Despite ED diagnosis and pain control management, 1 in 5 initial stone obstructed patients in the ED are admitted to the hospital to receive an urgent invasive temporary procedure, such as placing a stent or nephrostomy tube, to decompress the kidney (4,7,9). Surgical placement of a stent relieves pain and risk by allowing urine to pass, but does not remove the stone. The patient still undergoes expectant observation or is scheduled for surgery. As such, many patients end up requiring surgical intervention to remove the stone (9). Minimally invasive options include shock wave lithotripsy (SWL) and ureteroscopy laser lithotripsy (URS). Both have surgical risks and can yield pain. Neither is performed in the U.S. at point of care in the emergency department.

In our work, we are conducting a clinical trial of a non-invasive ultrasound-based solution to dislodge and reposition an obstructing stone to decompress the kidney, alleviate pain, and avoid hospitalization and urgent surgery.

References

1. NIDDK Urinary Stone Disease Research Opportunities and Challenges Workshop, March 2015. http://www.niddk.nih.gov/news/events-calendar/Pages/Urinary-Stone-Disease-Research-Challenges-Opportunities_04-2015.aspx

2. Scales CD, Jr., Smith AC, Hanley JM, Saigal CS. Prevalence of kidney stones in the United States. Eur Urol 2012;62:160-5.

3. Litwin MS, Saigal CS. Table 14-47: economic impact of urologic disease. In: Urologic Diseases in America. Washington, DC: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Public Health Service, US Dept of Health and Human Services; 2012:486. NIH publication 12-7865.

4. Yan JW, McLeod SL, Edmonds ML, Sedran RJ, Theakston KD. Risk Factors Associated with Urologic Intervention in Emergency Department Patients with Suspected Renal Colic. The Journal of Emergency Medicine 2015;49(2):130–5.

5. Harper JD, Ahn J, Acute Kidney Stone Management in Urologic Emergencies. in Acute Urology, Edit H. Wessells, Publisher: Wiley 2017 in press.

6. Pearle, MS, Calhoun, EA, Curhan, GC. Urologic diseases in America project: urolithiasis. J Urol 2005 March; 173:848-857. ?

7. Foster G (Social & Scientific Systems, Inc.), Stocks C (AHRQ), and Borofsky MS (New York University). Emergency department visits and hospital admissions for kidney stone disease, 2009. HCUP statistical brief #139. July 2012. Agency for healthcare research and quality, Rockville, MD.?

8. Scales CD Jr, Lin L, Christopher MS, Saigal CS, Bennett CJ, Ponce NA, Mangione CM, Litwin MS. NIDDK Urologic Diseases in America Project* Emergency Department Revisits for Patients with Kidney Stones in California. Acad Emerg Med 2015 Apr; 22(4):468-74.

9. Wang RC, Smith-Bindman R, Whitaker E, et al. Effect of Tamsulosin on Stone Passage for Ureteral Stones: A Systematic Review and Meta-analysis. Annals of Emergency Medicine 2017 Mar; 69(3):353-361. e3.

Task Progress & Bibliography Information FY2020 
Task Progress: This NASA funded study examines the ability of ultrasonic propulsion to dislodge and reposition acute obstructing ureteral stones from the ureteropelvic junction (UPJ) or the ureterovesical junction (UVJ) to relieve pain and obstruction, and/or to facilitate passage. Noninvasive manipulation of obstructing ureteral stones at the bedside would represent a breakthrough in the management of acute renal colic.

This is a 20-subject feasibility trial (NCT02028559). Patients presenting to either of two University of Washington Emergency Departments (ED) with an acute obstructing UPJ or UVJ stone are screened for inclusion. Standard of care is not interrupted. Once consented, participants undergo a pain assessment and the investigative procedure using a custom device capable of delivering ultrasonic propulsion for repositioning and burst wave lithotripsy (BWL) for dislodging. Success is measured via two outcomes: 1) movement of the stone, assessed by an independent radiologist blind to the therapy dose, and 2) safety, assessed in terms of prevalence and severity of adverse events associated with the therapy. Secondary outcomes include the reduction of hydronephrosis, the reduction of pain, and the passage of stones.

Fourteen participants have enrolled with stone sizes 3-9 mm. Motion was observed in one of two UPJ stone cases and two of eight UVJ stone cases. In four of six propulsion only cases, the UVJ stones passed within 24 hours. In the six UVJ cases with BWL dislodging pulses added, all stones passed within a few days. The fracture of one stone as a result of the dislodging pulses was visible on the ultrasound guidance. All subjects tolerated the procedure well. There were no serious or unanticipated adverse events. All non-serious adverse events were mild and self-limiting, and resolved spontaneously without intervention. No decrease in hydronephrosis was reported during the procedure.

Ultrasonic propulsion was observed to move about 1/3 of obstructing ureteral stones. The majority of UVJ stones treated with the investigative therapy passed. The technology may offer an adjunct or option to medical expulsive therapy and analgesics in managing obstructing stones. Randomized trials would be the next step to determine effectiveness and causality.

Bibliography Type: Description: (Last Updated: 02/20/2020)  Show Cumulative Bibliography Listing
 
Articles in Other Journals or Periodicals Harper JD, Metzler IS, Hall MK, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Williams JC Jr, Bailey MR, Sorensen MD. "First-in-human burst-wave lithotripsy (BWL) for kidney stone comminution," J Endourol. In review as of January 2020. , Jan-2020
Articles in Other Journals or Periodicals Hall MK, Samson PC, Kessler R, Lehnhardt K, Easter B, Thiel J, Wessells H, Bailey MR, Harper JD. "Pearl-Unjammed: the Seattle Stone Maneuver for Ureteropelvic Junction Urolithiasis." Journal of the American College of Emergency Physicians Open. Accepted, as of January 2020. , Jan-2020
Articles in Other Journals or Periodicals Sorensen MD, Samson P, Bailey MR, Harper JD. "Video: Ultrasonic propulsion of kidney stones." Urology Times. December 21, 2018. https://www.urologytimes.com/ytube/video-ultrasonic-propulsion-kidney-stones , Dec-2018
Articles in Peer-reviewed Journals Chen TT, Samson PC, Sorensen MD, Bailey MR. "Burst wave lithotripsy and acoustic manipulation of stones." Curr Opin Urol. 2020 Mar;30(2):149-56. https://doi.org/10.1097/MOU.0000000000000727 ; PubMed PMID: 31905177; PubMed Central PMCID: PMC7009318 , Mar-2020
Articles in Peer-reviewed Journals Bailey MR, Wang YN, Kreider W, Dai JC, Cunitz BW, Harper JD, Chang H, Sorensen MD, Liu Z, Levy O, Dunmire B, Maxwell AD. "Update on clinical trials of kidney stone repositioning and preclinical results of stone breaking with one system." Proceedings of Meetings on Acoustics. 2018 Nov;35(1):020004. https://doi.org/10.1121/2.0000949 , Nov-2018
Significant Media Coverage Sorensen MD, Samson P, Wessells H, Hall MK, Dunmire B, Cunitz BW, Bailey MR. "Ultrasonic Propulsion of Kidney Stones: Demonstration for Clinicians." YouTube video, November 27, 2018. https://www.youtube.com/watch?v=mBrkvVcG_Nc , Nov-2018
Significant Media Coverage Schmitt K. "The mobile ultrasound revolution: How technology is expanding this medical tool to new frontiers. CoInvestigator Dr. Michael Bailey is interviewed, as well as Principal Investigator Dr. M. Kennedy Hall." GeekWire podcast, January 23, 2019. https://www.geekwire.com/2019/mobile-ultrasound-revolution-technology-expanding-medical-tool-new-frontiers/ , Jan-2019
Project Title:  Renal Stone Ureter Management Technology Development and Clinical Validation Study Reduce
Images: icon  Fiscal Year: FY 2018 
Division: Human Research 
Research Discipline/Element:
ExMC:Exploration Medical Capabilities 
Start Date: 04/02/2018  
End Date: 04/23/2022  
Task Last Updated: 06/25/2019 
Download report in PDF pdf
Principal Investigator/Affiliation:   Hall, M. Kennedy  M.D. / University of Washington 
Address:  Dept. of Emergency Medicine 
 
Seattle , WA 98195 
Email: mkhall@uw.edu 
Phone: 206-744-8469  
Congressional District:
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Washington 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Wessells, Hunter  M.D. University of Washington 
Bailey, Michael  Ph.D. University of Washington 
Project Information: Grant/Contract No. Directed Research 
Responsible Center: NASA JSC 
Grant Monitor: Lehnhardt, Kris  
Center Contact: 281.244.0524 
kris.lehnhardt@nasa.gov 
Solicitation: Directed Research 
Grant/Contract No.: Directed Research 
Project Type: GROUND 
Flight Program:  
TechPort: No 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) ExMC:Exploration Medical Capabilities
Human Research Program Risks: (1) Medical:Risk of Adverse Health Outcomes & Decrements in Performance due to Inflight Medical Conditions (IRP Rev I)
 (2) Renal:Risk of Renal Stone Formation
Human Research Program Gaps: (1) Med12:We do not have the capability to mitigate select medical conditions (IRP Rev I)
Flight Assignment/Project Notes: NOTE: Start date changed to 4/02/2018 (from 4/24/2019) per K. Lehnhardt/ExMC element scientist (Ed., 2/19/2020)

Task Description: Kidney stones have long been near the top of NASA’s list of medical concerns. With this proposal we are addressing the following gaps from NASA's Human Research Roadmap ( https://humanresearchroadmap.nasa.gov ): Med 12 We do not have the capability to mitigate select medical conditions and Med 13 We do not have the capability to implement medical resources that enhance operational innovation for medical needs. Med 12 and 13 "will: 'Develop the capability to diagnose or treat renal stones in an exploration missions.' and 'Develop the relevant medical capabilities to technical maturity." The risk is that a stone, while innocuous when still in the kidney, will cause debilitating pain as it passes or worse, become obstructing, which can lead to urinary tract infection, sepsis, renal failure, and death. We propose a clinical trial of a countermeasure for this urgent condition which we have developed together with NASA.

Stones have plagued humans since ancient Egypt. One in eleven Americans has suffered from stones -- more than have diabetes or cardiovascular disease. Dehydration, stasis, and bone demineralization are strong contributors to kidney stones, and occur in microgravity, increasing the risk of stones in space. Stones are often debilitating, and pilots cannot fly with stones. Science, experience, and the negative medical consequences support concern for the risk of stones in space. NASA has focused considerable attention on stone mitigation and made progress. However, there are many types of stone disease, and it is unlikely that stone disease will ever be completely prevented on Earth or in space.

The impact of this project will be 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. The proposed work will expand the capabilities of the technology to meet the more advanced needs in space.

Rationale for HRP Directed Research: This research is directed because it contains highly constrained research. Due to weightlessness in space, it is believed that astronauts have a higher than normal probability to develop kidney stones. Novel, unique ultrasound technology developed by the University of Washington has been demonstrated to identify and move small renal stones within the kidneys. The next challenge with kidney stones is that they can block the ureteropelvic junction (UPJ) and ureterovesical junction (UVJ) positions of the ureter. This study will demonstrate that the ultrasound technology developed by the University of Washington can move renal stones blocking the UPJ and UVJ junctions thus relieving pain associated with hydronephrosis.

Research Impact/Earth Benefits:

Task Progress & Bibliography Information FY2018 
Task Progress: New project for FY2018.

Bibliography Type: Description: (Last Updated: 02/20/2020)  Show Cumulative Bibliography Listing
 
 None in FY 2018