New surgical procedure for enlarged prostates is approved by the FDA

Surgeons created what is today regarded as the gold standard therapy for benign prostatic hyperplasia (BPH), an age-related condition in which the flow of urine is obstructed by an enlarged prostate, over a century ago.

This surgery, known as a transurethral resection of the prostate, or TURP, is available to men who do not react to BPH medication. It entails using an electric loop to cut extra prostate tissue. About 90% of men who receive treatment experience long-lasting relief, although many are left unable to ejaculate and usually have to spend a night in the hospital recuperating.

There is less chance of problems and a quicker recovery with more recent, less invasive BPH treatments. These alternative techniques treat BPH in a different way than a TURP, which cuts directly into the prostate. For example, the obstructive tissues may be treated with lasers, steam, or microwaves.

The FDA approved another minimally invasive technique earlier this year, adding to the growing popularity of these operations. According to study results given at the 2023 Annual Meeting of the American Urological Association in April, the device known as the Optilume BPH catheter system offered long-lasting alleviation from BPH symptoms that held up after four years.

The process and the research

During an Optilume treatment, surgeons thread an inflated catheter toward the prostate using the urethra, the tube that empties the bladder of urine. By dividing the prostate's two lobes, the catheter makes a V-shaped channel in the gland's top, which lowers pressure on the urethra and increases urine flow rates. Crucially, paclitaxel, a chemotherapy medication, is coated on the catheter to help reduce inflammatory reactions brought on by the treatment. The prostate's duct is left behind once the catheter is taken out.

The urology professor Dr. Steven Kaplan of the Icahn School of Medicine at Mount Sinai in New York oversaw the research that resulted in the FDA's clearance. According to him, the new system's symptom improvements are on par with TURP's. He states, "We're pretty excited about it." "This is a potential game changer."

The International Prostate Symptom Score (IPSS), which goes from 0 to 35 and categorizes BPH as mild, moderate, or severe, was monitored during the study by Dr. Kaplan's group. The initial clinical trial, known as the PINNACLE study, which was restricted to men with prostates weighing between 20 and 80 grams, showed that Optilume therapy was immediately beneficial. After a year, males who received treatment had IPSS scores that were, on average, 11.5 points lower than those from the baseline.

An analysis and commentary
Men who were part of the second clinical trial, known as the Everest study, are currently undergoing follow-up assessments. However, the data that are now available, again for prostates weighing little more than 80 grams, demonstrate that four years following treatment, IPSS scores decreased from 22.5 at baseline to 11.5, with no discernible alterations in ejaculatory performance.

According to Dr. Heidi Rayala, an assistant professor at Harvard Medical School, urologist affiliated with Beth Israel Deaconess Medical Center, and member of the editorial board of the Harvard Medical School Annual Report on Prostate Diseases, "many innovative treatment alternatives for BPH have emerged over the years." "TURP remains the industry standard, despite the fact that several once-promising technologies have failed as a result of diminishing effectiveness over time. However, new developments such as Optilume have promising opportunities for increased endurance and fewer adverse effects.

It's important to remember that the prostate's size and the patient's symptoms affect how effective Optilume is. As patients and their urologists assess the best option from a range of minimally invasive treatments, matching the right surgical technique to the specific patient will continue to be essential.

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