Stents are used to open arteries that have narrowed from heart disease. Now doctors are considering them to treat erectile dysfunction to open the artery that supplies blood to the penis.
A recent but small pilot trial of the stents (tiny, wire mesh tubes) found that they may improve erectile function in some men.
The manufacturer of the stent, however, is suspending trials at this time because of challenges in identifying patients who will benefit from the procedure.
Krishna Rocha-Singh, MD, endovascular consultant at the Prairie Vascular Institute at St. John's Hospital in Springfield, Ill., and his fellow researchers followed 30 men who had a stent placed in their internal pudendal artery, which delivers blood to the penis. The average age of the subjects was 60.
Vascular disease, which blocks blood vessels, can cause erectile dysfunction in some men. Of the 30 patients with vascular disease, 19 completed the one-year study.
Investigators found that 16 of the men had a clinically significant advancement in sexual function. They noted that blood flow through the stented vessels was improved without any safety concerns.
While results were positive, challenges lie ahead.
Originally, 383 men were screened and accepted for inclusion in the study. But about 92 percent had to be excluded because their vascular disease was too advanced and could not be treated with the stent.
“Appropriate patient selection proved more difficult than anticipated,” said Joe McGrath, a spokesperson for Medtronic, the manufacturer of the stent. “Due to the diagnostic screening challenges encountered during the enrollment phase of the trial, we decided to suspend our clinical program for vasculogenic erectile dysfunction.”
The patient selection process has to be improved for any future studies.
McGrath added that erectile dysfunction represents a significant unmet medical need that persists despite the advent of PDE5 inhibitors (a class of vasodilators including Cialis, Levitra and Viagra).
“For the 30 to 50 percent of men with ED whose response to PDE5’s is considered suboptimal, alternative treatment options currently range from penile injections to prostheses,” said McGrath.
“Less invasive approaches that target a common root cause of the condition could include pelvic artery stenting, pending the results of future research,” he said.
Medtronic is currently under investigation by the US Senate for questionable practices in paying doctors to review and study its bone graft product, InFUSE.
An abstract of this study was presented at Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) conference in October in Miami. The research was sponsored by Medtronic, the manufacturer of heart stents, pacemakers and spine products.
Because the study has not yet been published in a peer-reviewed journal, the results should be considered preliminary.