Good news for men living with an enlarged prostate: clinicians have developed a novel way to treat Benign Prostate Hyperplasia (BPH) without sacrificing sexual function. On June 30, 2023, the FDA announced its approval of Optilume BPH for the treatment of an enlarged prostate.
“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,” said Steven A. Kaplan, MD, of Icahn School of Medicine at Mount Sinai, New York in a press release for The Journal of Urology.
Benign But Not Harmless
The word “benign” in benign prostate hyperplasia belies the effect on quality of life for men with an enlarged prostate. Symptoms include inability to control one’s bladder, urinary tract infections, bladder stones and kidney problems. In the past, patients were frequently told that sexual dysfunction was the price of treatment.
For example, existing solutions to prostate over growth include targeting the hormone testosterone. However, testosterone is also responsible for sexual health, and anti-testosterone drugs such as Proscrar often cause undesirable sexual side effects such as erectile dysfunction.
The PINNACLE Clinical Trial
In the hope of eliminating these difficult conversations, Urotronic Inc, the manufacturers of Optilume BPH, uprooted their approach to BPH.
Instead of a drug, researchers in the PINNACLE study tested whether a mechanical device would alleviate the symptoms experienced by men being treated for BPH. Optilume takes a two pronged approach, to first relieve the blocking of the urethra and second to stop the prostate from growing any further.
Essentially, Optilume BPH is a double-lobed balloon attached to a catheter. The lobes of the balloon inflate once they are positioned where the enlarged prostate is causing constriction. As a result, this widening of the urinary tract restores flow from the bladder. Optilume BPH is also coated with Paclitaxel, a drug that stops further growth of the prostate.
In the study, 148 men were implanted with the Optilume BPH or a sham. A sham is the surgical device equivalent of a placebo drug. In this case, the sham device was a catheter that was not dilated, and not coated with Paclitaxel. This way, the researchers could be sure that the effects observed were not due to the anesthesia used in surgery. They measured the effectiveness of the medicine using the International Prostate Symptom Score (IPSS), urinary flow rate, the size of the prostate and other measurements of quality of life. The subjects were evaluated on their quality of life at three months, six months and twelve months. They found that the Optilume BPH was effective in treating obstructed urinary flow while conserving sexual function in men.
Contraindications to the FDA
The Optilume BPH Catheter System should not be used in people who are:
- hypersensitive to paclitaxel or related medicines
- experiencing a urinary tract infection
- fitted with a penile prosthesis
- in possession of an artificial urinary sphincter
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.
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