As the number of men over the age of 50 presenting with benign prostatic hyperplasia (BPH) continues to grow, Mount Sinai is meeting the moment, adopting new approaches to diagnosis and treatment and engaging patients through new disease awareness and management applications.
One new technology, the Optilume® BPH Catheter System, is achieving good results among Mount Sinai patients. This innovative, minimally invasive system features two dilation catheters—an uncoated pre-dilation catheter and a drug-coated balloon catheter. The uncoated catheter is inserted and placed following cystoscopy and then inflated and held for approximately one minute to initiate an anterior commissurotomy, effectively widening the prostatic urothelium. The second balloon is then inserted, positioned, and held for 10 minutes to deliver a dose of paclitaxel to further widen the prostatic urothelium.
Alexis E. Te, MD, says the procedure, which does not involve resection of tissue, is typically completed in 15 minutes and patients are discharged with a foley catheter, which is removed after two days.
“Every patient is different, and their needs are different,” says Alexis E. Te, MD, Professor of Urology at the Icahn School of Medicine at Mount Sinai and Co-Director of the Men’s Health Program at Mount Sinai. “Our goal is to meet everyone’s needs by tailoring our therapies to each patient and finding new approaches that deliver better results for them.”
“The advantage of this system is that we are able to preserve our patients’ sexual function and achieve very good improvements in their symptoms with best-in-class flow rates at three to four years,” says Dr. Te, Professor of Urology at the Icahn School of Medicine at Mount Sinai and Co-Director of the Men’s Health Program at Mount Sinai.
Dr. Te adds that this therapeutic approach, which is best suited for patients with smaller prostates—approximately 20 to 80 grams—was assessed in a Mount Sinai-led double-blind study involving 18 centers in the United States and Canada. The study found that 100 patients who underwent Optilume BPH achieved a reduction in International Prostate Symptom Score of 11.5±7.8 points at one year post treatment versus a reduction of 8.0±8.3 points at three months in a sham cohort of 48 patients.
Furthermore, flow rate dramatically improved among the treatment cohort (+10.3 mL/s from baseline to one year, an increase of +125 percent). The study, “The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia,” was published in The Journal of Urology in September 2023.
Overall, Dr. Te says outcomes among patients who have undergone treatment with Optilume have been encouraging, and he has observed a lower rate of retreatment than other minimally invasive systems.
However, he cautions that the dataset is relatively limited. “We are treating several patients each month using the system, and we expect that will grow significantly over the next year once reimbursements for the system are settled,” Dr. Te says. “That is when we will begin to gain more long-term insights on factors such as retreatment.”
Patients undergoing surgical treatment for BPH are also benefiting from Mount Sinai’s investments in new technology, specifically the HYDROS Robotic system. This artificial intelligence-powered Aquablation platform enables greater customization of the procedure for each patient, with the added benefit of chip-on-tip imaging technology that delivers higher resolution ultrasound imaging than fiber optic technology. It also features more disposable components, which eliminates the need for re-sterilization.
“Mount Sinai played a key role in the development and refinement of Aquablation, and we were one of the first centers in New York City to introduce this new robotic system,” says Dr. Te. “With the upgrades, it is faster for us to plan and perform the procedure, not to mention safer for our patients because we are able to do all that using artificial intelligence.”
Even with these investments in new therapeutic approaches, the number of patients presenting with BPH—approximately 50 percent of men over the age of 50—is posing challenges for effective disease management.
Steven Kaplan, MD, FACS, Professor of Urology and Co-Director of the Men’s Health Program, and Dr. Te are investigating and adopting innovative approaches to BPH diagnosis and management.
Mount Sinai is addressing this through a partnership with Zeteo, a startup co-founded by Steven Kaplan, MD, FACS. The company has developed AI-powered applications—Zeteo Advocate and Zeteo Navigator—that help both physicians and patients make more informed, timely care decisions and better manage chronic disease. The applications are launching with BPH as the first featured disease state—a decision that reflects both the prevalence of the disease and the relatively small number of practicing urologists nationwide.
“Through the apps, patients can educate themselves about the disease and maintain a connection to their caregivers, while caregivers can develop a management plan that guides both of them on when to escalate care to a urologist,” says Dr. Kaplan, Professor of Urology at the Icahn School of Medicine at Mount Sinai, and Co-Director of the Men’s Health Program. “That benefits urologists because they can focus on recommending appropriate therapies and not have to first explain them to patients.”
Drs. Kaplan and Te are investigating and adopting other innovative approaches to BPH diagnosis and management. They are looking at the potential of using chip-on-tip technology in remote diagnostics to better assess changes in bladder function, developing new diagnostic algorithms to facilitate timely interventions, and exploring the feasibility of placing prostate stents as an alternative to medication.
“Every patient is different, and their needs are different,” Dr. Te says. “Our goal is to meet everyone’s needs by tailoring our therapies to each patient and finding new approaches that deliver better results for them.”