How a novel penile implant is offering hope to men with erectile dysfunction

Although the device is still in early testing phase, if milestones continue to be reached in a timely fashion, it could be on the market in 5-10 years

man-sitting-on-edge-of-bedAlthough technology related to the penis can draw childish sniggers, it is a serious business.

For instance, losing one’s erectile function through cancer or injury can be a life-altering event.

Erectile dysfunction is not uncommon; an estimated 40 percent of men aged 40-70 have some level of erectile dysfunction.

Of these 40 percent, an estimated one-third does not respond to drugs such as Viagra.

Brian Le, from the Department of Urology at the University of Wisconsin-Madison, recently investigated new technology that may, eventually, provide a reliable alternative.

Le joined forces with Alberto Colombo and Kevin McKenna at Northwestern University, IL, and Kevin McVary at Southern Illinois University. Le says that: “It’s a survivorship issue – restoring function can help people feel whole in their bodies again.”

Current treatments for erectile dysfunction

Beyond Viagra and similar drugs, there are two interventions that can restore some level of function.

The best solution on the market is an inflatable implant. However, due to the multiple components – including a reservoir of water and a pump – the surgery can be complicated. The implanted pump can also be awkward for the user, with the potential to cause medical complications, including water leakage from the internal reservoir.

The simplest device currently in use is a malleable implant. It is relatively cheap and easy to install, making it more popular in developing countries than in the United States. There are, however, drawbacks to this method. These include the fact that it provides a permanently erect penis, that it can change shape during use, and that it has the potential to put pressure on surrounding areas, therefore damaging tissue.

The inflatable pump technology was first designed in the 1970s and, since then, little progress has been made. Because neither of these interventions are ideal and because the potential marketplace is large, discovering alternatives could be lucrative. For these reasons, Boston Scientific is supporting Le’s innovative work in this field.

New penile implant technology

Le’s solution uses an exoskeleton made from Nitinol (a nickel-titanium alloy). Nitinol is already useful in endovascular surgery thanks to its super elastic properties.

The new implant is a heat-activated shape memory alloy, meaning that it has the ability to “remember” its original shape. At body temperature, the implant remains flaccid, but when heated, it unfurls to the expanded, elongated shape that it “remembers.”

A remote-controlled device is being designed that, when waved over the penis, will heat the Nitinol to just above body temperature, causing it to expand in length and girth.

Le and colleagues set out to test the Nitinol structure’s performance against other available devices. Mechanical tests mimicked those used by other penile prosthesis manufacturers; they included testing whether the structure buckled, penile lateral deviation, and the penis’ ability to recover its original shape.

The results are published in January’s edition of the journal Urology.

Testing showed that the Nitinol shape memory alloy has similar mechanical characteristics to inflatable penile prosthetics. They also showed that the new device became more pliable when deactivated and could be repeatedly used to attain an erection.

These early results are promising:

“We’re hoping that, with a better device, a better patient experience, and a simpler surgery, more urologists would perform this operation, and more patients would want to try the device.”

Brian Le

Although the device is still in the early testing phase, Le hopes that, if milestones continue to be reached in a timely fashion, the device could be on the market in 5-10 years.