FDA 批准治療前列腺肥大的新手術療法

Nearly a century ago, surgeons developed what is still considered the gold standard treatment for benign prostatic hyperplasia (BPH), an age-related disease that occurs when an enlarged prostate blocks the flow of urine. disease.

This procedure, called transurethral resection of the prostate (TURP), is suitable for men whose BPH has not responded to BPH medications and involves using an electric ring to trim excess prostate tissue. About 90 percent of men who receive treatment achieve lasting relief, but they often also have to spend a night recovering in the hospital, and many are unable to ejaculate.

Newer minimally invasive benign prostatic hyperplasia surgery offers faster recovery times and less risk of complications. While TURP cuts directly into the prostate, these alternative surgeries treat BPH in other ways, such as using steam, microwaves, or lasers to treat the blocking tissue.

Minimally invasive surgeries are growing in popularity, and earlier this year, another procedure received FDA approval. The system, called the Optilume BPH Catheter System, can provide sustained relief of persistent BPH symptoms four years later, according to study results presented in April at the American Urological Association's 2023 Annual Meeting.

Programs and Research

In the Optilume procedure, the doctor inserts an inflatable catheter into the prostate through the urethra (the tube that drains urine from the bladder). The duct divides the prostate into two halves (called lobes), creating a V-shaped channel at the top of the gland that reduces pressure on the urethra and increases urine flow. Importantly, the catheter is coated with the chemotherapy drug paclitaxel, which helps limit the inflammatory response associated with the treatment. After the catheter is removed, the channels in the prostate remain.

The study was eventually approved by the FDA. The improvement in symptoms achieved by the new system is comparable to that achieved by TURP. is a potential game changer.

During the study, the team measured changes in the International Prostate Symptom Score (IPSS), which ranges from 0 to 35 and classifies BPH as mild, moderate or severe. According to results from the first clinical trial, known as the PINNACLE study, which was limited to men with prostate sizes between 20 and 80 grams, Optilume treatment produced immediate results. After one year, treated men's IPSS scores were an average of 11.5 points lower than reported at baseline.

Follow up and comment

Follow-up evaluation of men participating in a second clinical trial, called the EVEREST study, is still ongoing. But the results to date (also for prostates no larger than 80 grams) show a decrease in IPSS scores from 22.5 at baseline to 11.5 after four years of treatment, without significant changes in ejaculatory function.

Over the years, many innovative treatment alternatives have emerged for BPH. TURP remains the benchmark as many initially promising technologies falter due to loss of efficacy over time. Nonetheless, recent advances like Optilume offer exciting prospects for enhanced durability and reduced side effects.

It's important to note that the effectiveness of Optilume varies based on prostate size and patient symptoms. As patients and their urologists evaluate the best options within the minimally invasive treatment spectrum, matching the appropriate surgical approach to the individual patient remains critical.

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