"The groundwork of all happiness is health." - Leigh Hunt

FDA approves latest surgical operation for enlarged prostate

Nearly a century ago, surgeons developed what continues to be considered the gold standard treatment for benign prostatic hyperplasia (BPH), an age-related condition that happens when an enlarged prostate urinates. Blocks the flow.

Offered to men who don't reply to BPH medications, the procedure, called transurethral resection of the prostate, or TURP, involves trimming away excess prostate tissue with an electrical loop. About 90% of treated men achieve lasting relief, but they typically need to spend an evening within the hospital recovering, and lots of remain unable to ejaculate.

Modern, minimally invasive BPH procedures offer faster recovery times and lower risks of complications. Where TURP cuts directly into the prostate, these alternative procedures treat BPH in other ways – for instance, through the use of steam, microwaves, or lasers to treat the obstructing tissue.

Minimally invasive procedures are gaining popularity, and one other one won FDA approval earlier this yr. Called the Optilume BPH Catheter System, it provided everlasting relief from BPH symptoms that continued 4 years later, in accordance with Results of the study Presented on the 2023 Annual Meeting of the American Urological Association in April.

Methodology and study

During an Optilume procedure, doctors insert an inflatable catheter through the urethra to the prostate, the tube that carries urine out of the bladder. The catheter divides the 2 parts of the prostate (called lobes), making a V-shaped channel at the highest of the gland that reduces pressure on the urethra, improving the speed of urine flow. Importantly, the catheter is coated with the chemotherapy drug, paclitaxel, which helps limit the inflammatory response to the treatment. After the catheter is removed, the channel stays within the prostate.

Dr. Steven Kaplan, professor of urology on the Icahn School of Medicine at Mount Sinai in New York, led the FDA-approved studies. Symptom improvements with the brand new system rival those achieved with TURP, he says. “We're pretty excited about it,” he says. “This is a potential game changer.”

During the study, Dr. Kaplan's team measured changes within the International Prostate Symptom Score (IPSS), which ranges from 0 to 35 and classifies BPH as mild, moderate or severe. According to the outcomes of the primary clinical trial, called the PINNACLE study and limited to men with prostate sizes between 20 and 80 grams, Optilume treatment showed immediate advantages. At one yr, IPSS scores in treated men were a median of 11.5 points lower than those reported at baseline.

Follow-up and commentary

Follow-up evaluations for men enrolled within the second clinical trial, called the EVEREST study, are still ongoing. But Results So far available—again for prostates larger than 80 g—show a drop in IPSS scores from 22.5 at baseline to 11.5 4 years after treatment, with no significant change in ejaculatory function.

“It is vital to notice that the efficacy of Optilume varies based on the scale of the prostate and the patient's symptoms. Matching the suitable surgical operation to the person patient shall be vital as patients and their urologists consider minimally invasive treatments. examines one of the best selections inside a spectrum of