Faced with a growing number of patients who are presenting with benign prostatic hyperplasia (BPH) due to an aging population, Mount Sinai researchers are leading the effort to assess and validate new technologies to gain more insights and achieve improved outcomes.
That effort is being led in part by Steven Kaplan, MD, FACS, who is exploring the potential of remote diagnostics to deliver more detailed and accurate urinary flow data to enhance decision-making in weighing treatment options.
“The ability to do multiple measures for anything, whether it is blood pressure or flow rates, is going to deliver more accurate insights about what is going on with a patient than taking one measurement in the office,” says Dr. Kaplan, Professor of Urology at the Icahn School of Medicine at Mount Sinai.
“Using artificial intelligence, we can combine this data to make better predictions as to which patients will respond to a particular therapy and spare others from receiving unnecessary therapies.”
Steven Kaplan, MD, FACS, Professor of Urology at the Icahn School of Medicine at Mount Sinai and Director of the Men’s Wellness Program
Dr. Kaplan has been piloting one such technology, CarePath®, a home uroflow data device developed by I-O Urology.
He conducted a retrospective study among 465 Mount Sinai patients (mean age 67.4) looking at both overall (15,521) and single-day (4,347) voids to assess how representative 24-hour data collection is of patient experience. The study, “The Role of Remote Diagnostics to Better Assess Uroflow Variability: Insights From Combining at Home Uroflows and Frequency Volume Charts From 19,868 Voids Using a Novel, Hand Held, Cellular Embedded Device,” was published in the August 2024 edition of Urology.
Based on patient data, Dr. Kaplan noted that the average Qmax was 11.2 mL/s (95 percent CI: 10.80, 11.65) and 11.2 mL/s (95 percent CI: 10.81, 11.64) in the 24-hour and overall study groups, respectively. Both groups had similar between (20.3 percent versus 20.4 percent) and within-subject (12.0 percent versus 11.9 percent) variance. The difference in peak urinary flow rate (Qmax) was not significantly different (P = .970). A subgroup analysis including voids >150 mL yielded similar results.
“We found that if patients performed approximately 10 urine flow measures at home over the course of four or five days, that was all we needed,” Dr. Kaplan says. “Based on that, we could almost predict what the eleventh measurement would be. The goal now is to look at the technology’s predictive value.”
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Mount Sinai is also leading the effort to validate the efficacy and safety of noninvasive treatments for BPH.
A team of researchers, including Alexis E. Te, MD, conducted a prospective study of outcomes among 330 Mount Sinai patients who underwent Aquablation®, which achieves precise removal of prostate tissue through the use of a computer-controlled, heat-free waterjet, between December 2019 and December 2023. The study, “Aquablation at 4-years: Real World Data From the Largest Single-center Study With Associated Outcomes Follow-up,” was published in Urology in May 2024.
The mean prostatic volume among this cohort was 110.3 mL (range 38-330 mL) at baseline. The research team noted an improvement in International Prostate Symptom Score (IPSS) from a baseline of 23.8 (SD 8.4) to 6.9 (SD 2.9) at four years. They also observed an improvement Qmax, which increased from 6.4 mL/sec (SD 4.2) to 17.4 mL/sec (SD 5.5) at four years. At one year, the mean prostate volume reduction was 45.5 mL (-41.3 percent). The research team also achieved postoperative antegrade ejaculation preservation among 249/250 men.
“Based on the results we are seeing, it has been a game changer,” says Dr. Te, Professor of Urology at the Icahn School of Medicine at Mount Sinai. “It has essentially reduced what used to be a one-to-two-hour procedure to one that is completed in 30 to 45 minutes, with preservation of sexual function among 90 percent of patients.”
“Based on the results we are seeing, it has been a game changer,” says Alexis E. Te, MD, Professor of Urology.
Drs. Kaplan and Te are exploring other opportunities for achieving better outcomes among patients presenting with BPH. They include clinical trials to assess the potential of prostate stents to facilitate urination and the investigation of new Aquablation technology that could result in faster, more precise treatment. Additionally, Drs. Kaplan and Te continue to refine their approach to Aquablation, achieving zero transfusion rates and enhanced patient convalescence.
But it is diagnostic technologies that Dr. Kaplan believes hold the greatest promise for patient outcomes.
“That, for me, is the growth area more than the therapies,” Dr. Kaplan says. “Because if we get the diagnosis right, we can reduce the reliance on therapies.”
New Initiative With American Urological Association Encourages Investment in Urologic Medical Technology
In the rush to invest in social media, artificial intelligence, and cryptocurrencies, Steven A. Kaplan, MD, Director of the Men's Wellness Program, Mount Sinai Health System, has noted that one area is being overlooked: medical technology.
“There is not enough investment being made, not just in the field of urology but across all of the subspecialities,” says Dr. Kaplan, who is also Professor of Urology, Icahn School of Medicine at Mount Sinai. “We need to be more aggressive in making that happen so the field does not lay fallow.”
That thinking informs the American Urological Association’s Innovation Nexus. Spearheaded by Dr. Kaplan, the association’s chair of research, this biannual conference aims to advance urologic discovery to solutions that improve patient care and save lives through access to a wide range of business development supports. They include discussion forums, mentorship, networking, and access to investors.
“This is a platform that will enable clinicians and researchers to bring their ideas forward and, if they have merit, build companies to commercialize them,” says Dr. Kaplan.
The organization has held two conferences that offered urologists opportunities to present their ideas and garner interest from mentors and investors. Dr. Kaplan says they have received strong support from industry innovators such as Meghan Scanlon, Senior Vice President and President, Urology, Boston Scientific, who served as the keynote speaker at the May 2024 conference. They have also resulted in several startups achieving series A funding, a first round of investment.
“We have a ‘Shark Tank’-style competition with 12 applicants for the first conference, 19 for the second one, and we already have 35 for the next one, so the word is getting out about it,” Dr. Kaplan says.
Dr. Kaplan’s goal is to build on initial interest and achievements to ensure that Innovation Nexus is positioned for continued success when he steps down as chair.
“I want it to be a platform that is not dependent on me, but on the structure and the people who operate it,” he says. “But more than that, I want it to be a template that other specialties can follow.”