BPH treatment device may improve sexual function

In a randomized, blinded, sham-controlled study, 122 patients showed statistically significant improvements in five of seven sexual function categories after treatment with the TMx-2000 (American Medical Systems/TherMatrx, Inc., Minnetonka, MN), with no serious side effects.

"At first glance, you wouldn't anticipate that happening," said Gregg R. Eure, MD, assistant professor of urology at Eastern Virginia Medical School in Norfolk. "But in the past several years, more and more research is pointing toward BPH as an independent risk factor for erectile dysfunction. So perhaps if you improve a patient's BPH, you'll improve his ED, as well."

The researchers initially randomized 200 patients to either active or sham treatments in seven physician offices. Patients had an AUA Symptom Index score >12, peak flow rate <12 mL/sec, and cystoscopic BPH.

Sixty-one patients received sham treatments in which a treatment catheter was placed and the TMx-2000 machine was turned on to simulate an actual treatment session. Sham patients were unblinded after 3 months.

Among the 122 patients who received active treatments and on whom follow-up data were available, there were significant 3-month improvements in mean erection score (5.4 to 6.0, p=.011), ejaculation score (4.4 to 5.0, p=.012), problem score (6.2 to 7.5, p<.000), and total sexual score (24.8 to 27.81, p<.000).

More importantly, active-treatment patients experienced statistical improvement in five categories from baseline to 12 months:

"You can't come out and say, 'Let's treat ED with a microwave,' but this does tell us that the [TMx-2000] is safe to use when it comes to sexual side effects," said Dr. Eure, who was an investigator in early trials for the TMx-2000 and has served as a consultant for TherMatrx.

There were no significant changes in sexual parameters among the 61 sham patients, again with no serious side effects from their simulated treatments.

"We believe this device is a safe, in-office microwave treatment that will almost certainly not have any negative impact on sexual function and needs to be evaluated more extensively, but that may in fact improve sexual function in some patients," concluded Dr. Eure, who worked with colleagues Chris Tepera, MD, and Kevin Bordeau, MD, on the study.