Oct. 15, 2009— -- People may be used to getting spam e-mails offering discounts on Cialis, Levitra or Viagra, but if a new clinical trial is successful, men with erectile dysfunction may someday be flooded with e-mails for another option: a stent.
Medtronic has begun testing on a new pelvic stent for men who have not been helped by drugs. Investigators will begin with 50 patients at 10 different medical centers.
"This is a common problem. Men many times do not have satisfactory results from first-line medical therapies," said Dr. Krishna Rocha-Singh, director of the Prairie Vascular Institute in Springfield, Ill., who installed the first of the stents in a patient last week.
Singh said erectile dysfunction can also be a sign of larger problems, with potential blockages of major blood vessels.
"Erectile dysfunction could be a symptom of a vascular source," he said, noting that it could be an early sign of what could lead to heart attacks or strokes. "The patients we're treating in our practice [with erectile dysfunction] had the same problem elsewhere in other parts of the body."
By opening up blood flow, Singh explained, stenting might solve some of those problems. However, he pointed out, it remains to be seen which patients would be helped by the stent, a question he hopes the clinical trial will answer.
Other doctors in the field said the device may prove beneficial, but only to a small subset of men.
Dr. Jerome Richie, the chief of urology at Brigham and Women's Hospital in Boston, said, "I would foresee this stent as an application for younger individuals who have had traumatic injuries that decrease arterial inflow. Other than that selected group, I do not foresee widespread applicability."
Dr. Ajay Nehra, a professor of urology at the Mayo Clinic, agreed that young men whose erectile dysfunction stemmed from traumatic injury would be the most likely to be helped, and said they may prefer a stenting operation to a pill, since an erection would not feel as medically induced later on.
"Men would ideally like to have natural, spontaneous erection, and that's why the medical device is trying to look at alternative options than pills, per se," said Nehra.
Will There Be Demand?
For many men with erectile dysfunction, the available pills do not help. For that reason, a number of doctors thought the stent could become a commercial success.
"Current ED meds (Viagra, etc.) work in only about half of patients, so if this were effective, it could have substantial impact," said Dr. Martin Sanda, director of the prostate cancer center at Beth Israel Deaconess Medical Center in Boston.
And while a stent may be thought of as invasive, doctors did not think that would be an obstacle if the stent proved to be successful.
"Regarding the potential splash it could make, take a look at the splash Viagra made. If [women are] willing to have surgery for breast implants etc., and men are willing to get penile implants, I would think the potential for this could be huge, if it works and has minimal side effects," said Dr. Lee E. Ponsky, chief of the division of urologic oncology at University Hospitals Case Medical Center in Cleveland.
"For men [in whom] pills or vacuum devices do not work, this method of drug delivery may be better accepted than the current suppositories or direct injection into the penis. It will be an interesting trial to follow," said Dr. Martha K. Terris, chief of urology at the Augusta VA Medical Center in Georgia.
Other doctors agreed that demand would not be a problem if the trial were successful.
"All men with erectile dysfunction will want to know if they are candidates for the stent," said Dr. Ira Sharlip, a clinical professor of urology at the University of California at San Francisco, and immediate past president of the International Society for Sexual Medicine.
At the same time, he said, "[It] remains to be seen if it works and for whom."