Treatment with the recently approved, minimally invasive Optilume BPH device improves urinary symptoms while preserving sexual function in men with benign prostatic hyperplasia (BPH), concludes a randomized trial within the September issue of The Journal of Urology^®, an Official Journal of the American Urological Association (AUA). The journal is published within the Lippincott portfolio by Wolters Kluwer.

The subsequent-generation Optilume BPH Catheter System offers a secure and effective recent, minimally invasive treatment for BPH, reducing urinary obstruction with a low rate of sexual or other adversarial effects, in a straightforward outpatient procedure.”

Steven A. Kaplan, MD, Lead Creator, Icahn School of Medicine at Mount Sinai, Recent York

Sham-controlled trial helps define Optilume’s advantages and safety

Benign prostatic hyperplasia is a quite common condition, estimated to affect as much as 80% of men by age 80 years. It occurs when aging-related enlargement of the prostate gland causes lower urinary tract symptoms, resembling frequent and difficult urination.

Available treatments include medications and surgery. Each have limitations, including a risk of problems with sexual functioning after surgery. Various minimally invasive treatments have been developed to bridge the gap between these options, with mixed results.

The Optilume BPH Catheter System offers a brand new sort of minimally invasive treatment, featuring a dual mechanical and pharmacological mechanism of motion. Within the Optilume procedure, an uncoated balloon catheter is used to open a passage between the lateral lobes of the prostate (anterior commissurotomy).

A second balloon, coated with the antiproliferative drug paclitaxel, is then deployed to further widen the opening. The addition of paclitaxel is believed to forestall continued enlargement of the prostate and stop re-fusion of the lateral lobes. The Optilume BPH system was approved by the US Food and Drug Administration earlier this yr.

The brand new trial, called PINNACLE, included 148 men with symptomatic BPH all had urinary flow obstruction of about 30% because of impingement by the enlarged prostate. The patients, average age 65 years, were enrolled at 18 sites in america and Canada

100 patients were assigned to undergo energetic treatment with Optilume. The remainder underwent a sham procedure to mimic Optilume treatment. Neither the patients nor the researchers evaluating outcomes were aware of which treatment the patient received through 12 months of follow-up. Men assigned to the sham procedure had the chance to undergo energetic treatment in a while.

Lasting improvement in BPH symptoms – No adversarial effects on sexual function

Men undergoing energetic Optilume treatment had greater improvement in BPH-related symptoms, as shown by the usual International Prostate Symptom Rating (IPSS). From an initial value of about 24 (on a spread from 0 to 35), IPSS rating decreased by a median of 11.5 points with Optilume versus 8.0 points with sham treatment.

The development was maintained through 12 months’ follow-up within the Optilume group, but not within the sham group. About three-fourths of patients undergoing Optilume treatment had a minimum of 30% improvement on the IPSS, in comparison with one-third of the sham group.

The Optilume group also had a dramatic increase in urine flow rate, greater than with previous minimally invasive treatments; and significant improvement in scores for quality of life. Opposed effects were generally mild to moderate. Importantly, sexual function was not adversely affected, including erectile and ejaculatory function.

Treatment with the Optilume BPH Catheter System is a “straightforward procedure” that could be performed in an outpatient or office setting, with easy sedation and pain control. Dr. Kaplan and coauthors conclude: “This minimally invasive treatment represents a horny choice to patients looking to take care of sexual function while achieving durable symptom relief and improved flow.”