Inflating a drug-coated balloon in the prostate is the latest approach to treating a common cause of frequent or difficult urination in older men.
As the prostate naturally grows with age, the gland can obstruct the flow of urine – leading to frequent trips to the bathroom and disrupted nights. An estimated 50% of men aged 60 years and older have benign prostatic hyperplasia (BPH). That figure rises to more than 80% by age 70 and to 90% by age 80.
Transurethral resection of the prostate was the main surgical treatment for symptomatic BPH for much of the 20th century.
More recently, researchers have developed various minimally invasive surgical therapy (MIST) devices to treat the obstruction while limiting effects on sexual function. Some newer devices use lasers or water vapor to remove prostate tissue. Another approach uses implants to move and hold prostate tissue out of the way.
Now drug-coated balloons have entered the picture.
, paclitaxel – best known as a chemotherapy medication – to limit further growth and keep the lobes apart.
The Food and Drug Administration approved Optilume BPH in June. The results from a randomized controlled trial of the device were published in The Journal of Urology.
Uptake of MIST devices for BPH “has been variable due to a host of factors including mixed results, complexity of equipment, and costs,” the journal’s editor, D. Robert Siemens, MD, noted in the issue.
The developer of the device, Urotronic, said it expects that the newest treatment will be commercially available in the near future. Discussions about cost, insurance coverage, and how to train urologists to use it are ongoing, said Ian Schorn, the company’s vice president of clinical affairs.
Raevti Bole, MD, a urologic surgeon at Cleveland Clinic’s Glickman Urological and Kidney Institute, said BPH treatments ideally benefit patients for years, so she is eager to see how patients are doing 5 and 10 years after the Optilume BPH procedure. Studies should also examine its effects on fertility.
But given the safety and efficacy results reported 1 year after treatment, “I think this is something that a lot of people are going to be able to use in their practice and that their patients are going to benefit from,” Dr. Bole told this news organization.
She said she expects most urologists will be able to master the technology. The procedure’s minimal effect on sexual issues and the relatively short time needed to perform it are other advantages.
“All of those things are very positive in terms of whether patients are going to want to consider it and also whether surgeons are going to be able to realistically learn it and offer it at their centers,” Dr. Bole said.
In choosing a particular treatment, Dr. Bole discusses options with patients and takes into account factors such as trial data, the nature and severity of symptoms, treatment goals, comorbidities, and the size of the prostate.
Available MIST devices can vary by institution, and urologists can have different levels of experience with each device. If a patient is interested in an approach a surgeon does not offer, the surgeon can refer the patient to a colleague who does.