New Treatment for Enlarged Prostate Approved by FDA

Introduction to Optilume BPH

Men suffering from an enlarged prostate can now benefit from a groundbreaking treatment approach for Benign Prostate Hyperplasia (BPH). On June 30, 2023, the FDA granted approval for the Optilume BPH Catheter System, which offers a novel method that maintains sexual function during treatment. Dr. Steven A. Kaplan from the Icahn School of Medicine at Mount Sinai, New York, mentioned in a press release for The Journal of Urology, “The next-generation Optilume BPH Catheter System offers a safe and effective new, minimally invasive treatment for BPH, reducing urinary obstruction with a low rate of sexual or other adverse effects, in a simple outpatient procedure.”

Understanding Benign Prostate Hyperplasia

Despite the term “benign” in benign prostate hyperplasia, the condition can significantly impact the quality of life for men. Symptoms often include difficulty controlling bladder function, urinary tract infections, bladder stones, and potential kidney issues. Historically, patients have been informed that sexual dysfunction is an inevitable consequence of treatment.

Current Treatment Limitations

Traditional treatments for prostate enlargement often focus on hormonal intervention, specifically targeting testosterone. However, since testosterone is crucial for sexual health, medications such as Finasteride can lead to adverse sexual side effects, including erectile dysfunction.

The PINNACLE Clinical Trial

Innovative Research Approach

To address the issues associated with existing treatments, Urotronic Inc., the creators of Optilume BPH, shifted their focus from pharmacological solutions to a mechanical device aimed at alleviating BPH symptoms. The PINNACLE study specifically investigated whether a device could effectively relieve symptoms without compromising sexual function.

How Optilume BPH Works

Optilume BPH employs a dual-action mechanism. It features a double-lobed balloon attached to a catheter that inflates once correctly positioned to relieve urethral obstruction. This expansion restores urinary flow from the bladder. Additionally, the balloon is coated with Paclitaxel, a medication that inhibits further prostate growth.

Study Results and Effectiveness

In the clinical trial, 148 men were implanted with either the Optilume BPH device or a sham device, which acted as a placebo. This sham device was a catheter that did not inflate or contain Paclitaxel, ensuring that observed effects were not attributable to anesthesia. Researchers utilized the International Prostate Symptom Score (IPSS), urinary flow rate, prostate size, and other quality of life metrics to evaluate treatment effectiveness over three, six, and twelve months. Results indicated that Optilume BPH effectively treated obstructed urinary flow while preserving sexual function.

Contraindications for Optilume BPH

The FDA advises that the Optilume BPH Catheter System should not be used in individuals who are:
– Hypersensitive to Paclitaxel or related medications
– Experiencing a urinary tract infection
– Fitted with a penile prosthesis
– In possession of an artificial urinary sphincter

References

US Food and Drug Administration. Recently approved medical devices. Optilume BPH Catheter System – P220029. Published July 19th, 2023. Accessed September 5th, 2023.
Steven A. Kaplan et al., 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. Journal of Urology. 2023; 210 (3) 500-509. doi: 10.1097/JU.0000000000003568
Press Release: “Next-generation treatment reduces symptoms, preserves sexual function in men with enlarged prostate” Optilume provides new approach to minimally invasive treatment, reports The Journal of Urology.