Erectile dysfunction (ED) is a common issue in men in which they struggle to get an erection or sustain an erection long enough for satisfying sex. ED is especially common in men with spinal cord injuries (SCI), which is damage to the nerves in the spine that send signals between the brain and the body.
ED with an SCI is likely related to a disruption in the system that signals arousal and erection. This may not be able to be treated by traditional methods like phosphodiesterase inhibitors (PDE5-i's) – commonly known as Viagra or Cialis. Other standard ED treatments include vacuum erection devices, penile injections, and surgically placed implants.
Some non-conventional methods have been tested recently, including electrical stimulation, which has shown improvement in patient erections. An experimental penile implant has been tested recently, which would allow men to use electrical stimulation at home to improve erectile function. This device was invented based on the idea that controlled electrical stimulation can enhance brain signals and blood flow response.
Researchers aimed to test the safety and tolerability of this implantable neurostimulator in men with traumatic SCI and ED. Six men with a median age of 33 and at least 3.5 years with an SCI and ED were recruited for a clinical trial. After the implant surgery, in which the neurostimulator was placed in the penis, researchers followed up at 14, 44, 90, 180, and 360 days, as well as conducted biweekly phone check-ins for any complications and device malfunctions.
At the pre-surgery and follow-up appointments, patients completed surveys assessing their level of erectile dysfunction (ED), including the International Index of Erectile Function (IIEF-15), with particular focus on the erectile function domain score (IIEF-EF), as well as the Erection Hardness Scale (EHS), which rates erection firmness on a scale from 0 to 4. Researchers say that no patients reported complications during the entire year of follow-up, and no patients withdrew from the study. This suggests that the device is likely tolerable, and patients did not actively dislike its function, although the small size of the group should be considered.
The IIEF-15 and IIEF-EF scores both improved significantly over the one-year timeframe. This positive change in results suggests that the device did improve erectile function in this group of men with SCI. However, the EHS improved over one year but did not show any statistical significance. Researchers say these results support future research and experimental use, if governing bodies recommend it.
This study is supported by previous research on electrical and neurostimulation, and it aligns with a growing body of research. It appears more researchers are interested in further research on ED treatments in special populations.
Researchers say the results also support the idea that targeted electrical stimulation of this specific area of nerves is safe and presents a possible approach to ED treatment in SCI patients. However, because this study included a very small group and did not have a control group to compare results with, there is no way to say for sure whether these results can be translated to a larger population just yet. More research with larger sample sizes is needed to show that this device works as intended and to determine whether the results would lead to clinically significant improvements in erectile function and safety compared with intracavernosal injections (ICI) and penile prostheses, which are the standard of care for patients who have failed oral therapies.
Key Takeaways
Resources
Glina, S., Seligra-Lopes, L., Lessa, P. F., Jost, R. T., Glina, F. P., Cintra, C. C., de Castro Neves Neto, O., Juliano, R. V., Seabra Rios, L. A., Fraga-Silva, R. A., Sturny, M., Stergiopulos, N., & Burnett, A. L. (2026). Safety and tolerability of a novel implantable neurostimulator to improve erectile function: A pilot study in patients with Spinal Cord Injury. The Journal of Sexual Medicine, 23(5). https://doi.org/10.1093/jsxmed/qdag111
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