Objective: Our goals were to validate stone comminution with an investigational burst wave lithotripsy (BWL) system in patient-relevant conditions and to evaluate the use of ultrasonic propulsion to move a stone or fragments to aid in observing the treatment endpoint. Materials and Methods: The Propulse-1 system, used in clinical trials of ultrasonic propulsion and upgraded for BWL trials, was used to fragment 46 human stones (5-7 mm) in either a 15-mm or 4-mm diameter calix phantom in water at either 50% or 75% dissolved oxygen level. Stones were paired by size and composition, and exposed to 20-cycle, 390-kHz bursts at 6-MPa peak negative pressure (PNP) and 13-Hz pulse repetition frequency (PRF) or 7-MPa PNP and 6.5-Hz PRF. Stones were exposed in 5-minute increments and sieved, with fragments >2 mm weighed and returned for additional treatment. Effectiveness for pairs of conditions was compared statistically within a framework of survival data analysis for interval censored data. Three reviewers blinded to the experimental conditions scored ultrasound imaging videos for degree of fragmentation based on stone response to ultrasonic propulsion. Results: Overall, 89% (41/46) and 70% (32/46) of human stones were fully comminuted within 30 and 10 minutes, respectively. Fragments remained after 30 minutes in 4% (1/28) of calcium oxalate monohydrate stones and 40% (4/10) of brushite stones. There were no statistically significant differences in comminution time between the two output settings ( p = 0.44), the two dissolved oxygen levels ( p = 0.65), or the two calyx diameters ( p = 0.58). Inter-rater correlation on endpoint detection was substantial (Fleiss' kappa = 0.638, p < 0.0001), with individual reviewer sensitivities of 95%, 86%, and 100%. Conclusions: Eighty-nine percent of human stones were comminuted with a clinical BWL system within 30 minutes under conditions intended to reflect conditions in vivo. The results demonstrate the advantage of using ultrasonic propulsion to disperse fragments when making a visual determination of breakage endpoint from the real-time ultrasound image.
INTRODUCTION AND OBJECTIVE: Erectile dysfunction (ED) treatments are effective and widely available. While it has been previously demonstrated that different races in the United States display varied prevalence of ED it remains uncertain whether treatment-seeking patterns differ by race/ethnicity. In this present study, we examine the relationship between race and erectile dysfunction treatment.METHODS: We performed a retrospective review using Optum's De-identified ClinformaticsÒ Data Mart database. Administrative diagnosis, procedural, and pharmacy codes were used to identify male subjects 18 years and older with a diagnosis of ED between 2003 and 2018. Demographic variables (i.e. race, education level, and income level) and clinical factors were identified. Men with less than a year of enrollment before or after ED diagnosis were excluded. Men with a history of prostate cancer were excluded. Types and patterns of ED treatment (oral agents, intraurethral agents, intracavernosal injection, vacuum erection device, and surgery) were analyzed after adjusting for age, income, education, frequency of urologist visits, smoking status, and metabolic syndrome (MetS) comorbidity diagnoses. All analyses were performed in SAS software version 9.4 (SAS Institute Inc., Cary, NC).RESULTS: During the observation period, 810,916 men were identified who met the inclusion criteria with a median follow-up time of 3.8 years. 74.9% of the patients were Caucasian, 10.5% were African American (AA), 11.5% were Hispanic, and 3.1% were Asian. Caucasian and Asian men reported higher educational attainment and annual income. 34.6% of Caucasians, 36.4% of AAs, 29.% of Hispanics, and 30.8% of Asians underwent any ED treatment. 0.27% of Caucasians, 0.44% of AA, 0.21% of Asians, and 0.40% of Hispanic men underwent surgery for ED. After matching for demographic and clinical factors, differences in ED treatment persisted. Compared to Caucasians, Asian and Hispanic men had significantly lower odds of undergoing any ED treatment (OR 0.81 and 0.85 respectively), while AAs had higher odds of ED treatment (OR 1.13). Of men who underwent ED treatment, AA and Hispanic men were more likely to undergo surgery than Caucasian men (OR 1.19 and 1.37 respectively).CONCLUSIONS: Differences in ED treatment patterns exist across racial groups even after accounting for socioeconomic variables, and Asian and Hispanic men are less likely to receive ED treatment. Whether this finding is due to patient preference, physician or health system biases, or a combination of factors, an opportunity exists to further investigate potential barriers to men receiving care for sexual dysfunction.
Purpose of review Burst wave lithotripsy and ultrasonic propulsion of kidney stones are novel, noninvasive emerging technologies to separately or synergistically fragment and reposition stones in an office setting. The purpose of this review is to discuss the latest refinements in technology, to update on testing of safety and efficacy, and to review future applications. Recent findings Burst wave lithotripsy produced consistent, small passable fragments through transcutaneous applications in a porcine model, while producing minimal injury and clinical trials are now underway. A more efficient ultrasonic propulsion design that can also deliver burst wave lithotripsy effectively repositioned 95% of stones in 18 human participants (18 of 19 kidneys) and clinical trials continue. Acoustic tractor beam technology is an emerging technology with promising clinical applications through the manipulation of macroscopic objects. Summary The goal of the reviewed work is an office-based system to image, fragment, and reposition urinary stones to facilitate their natural passage. The review highlights progress in establishing safety, effectiveness, and clinical benefit of these new technologies. The work is also anticipating challenges in clinical trials and developing the next generation of technology to improve on the technology as it is being commercialized today.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.