Lba01-06 randomized Control Trial of Ultrasonic Propulsion to Facilitate Clearance of Chronic Residual Fragments

Abstract

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.

Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans

“…BWL's short harmonic bursts of ultrasound from a handheld therapy and imaging transducer have been well tolerated with minimal hematuria by awake patients. 9,10 As a precursor to a clinical effectiveness study, the study reported here was designed to directly observe how well BWL fragmented stones and any tissue injury associated with the procedure. As such, we recruited subjects already undergoing ureteroscopy (URS), and while the subjects were anesthetized, we applied 10 minutes of BWL and then used the ureteroscopic video to assess for fragmentation and injury.…”

“…We addressed this unmet need by developing an office-based ultrasound system to image, break and reposition stone fragments to facilitate their natural clearance. 5 A stepwise progression of development and human trials has ensued, 6–10 and this paper reports on the first human feasibility study of our technology called burst wave lithotripsy (BWL) 11 to fragment stones. BWL’s short harmonic bursts of ultrasound from a handheld therapy and imaging transducer have been well tolerated with minimal hematuria by awake patients.…”

“…BWL’s short harmonic bursts of ultrasound from a handheld therapy and imaging transducer have been well tolerated with minimal hematuria by awake patients. 9,10…”

Recent Advances in the Science of Burst Wave Lithotripsy and Ultrasonic Propulsion

“…Independent review of these videos determined that motion ≥ 3 mm had occurred in 18 of 19 kidneys (95%). Data from the most recent clinical study presented at the 2021 meeting of the American Urological Association suggests that ultrasonic propulsion may help relieve pain and accelerate passage of distal ureteral stones [ 35 ], as well as chronic residual fragments [ 36 ]. In the case of this latter study, a subject reported never passing fragments following SWL.…”

First Series Using Ultrasonic Propulsion and Burst Wave Lithotripsy to Treat Ureteral Stones

“…A stepwise progression of development and human trials has ensued. [5][6][7][8][9] The present study focused on treating distal and proximal ureteral stones, with emphasis on facilitating passage of distal stones into the bladder and pushing proximal stones back into the kidney. Distal ureteral stones are more common than proximal ureteral stones; both are more common and more reliably visualized with ultrasound than middle ureteral stones.…”