CaverSTIM device shows initial promise for post-prostatectomy erectile dysfunction

Data from a first-in-man clinical study (NCT05650866) of the CaverSTIM device have been published in BJU International, showing encouraging outcomes with the implantable cavernous nerve neurostimulator in restoring erectile function following robot-assisted radical prostatectomy (RARP).¹

In addition to the early phase trial results, a review on the scientific rationale for using implantable neurostimulation was concurrently published in Nature Urology Review.²

“These publications reflect a major step forward for CaverSTIM and for Comphya,” said Pim van Wesel, CEO of Comphya, in a news release from the company.² “Seeing our technology validated in a first-in-man clinical study reinforces our confidence that neuromodulation can meaningfully improve quality-of-life outcomes for men undergoing prostate cancer surgery. This progress is an important milestone as we work toward making erectile function rehabilitation a realistic expectation rather than an exception.”

First-in-man study

In total, the prospective pilot study included 10 men who were potent before undergoing RARP. All patients received the CaverSTIM implant during the procedure and were asked to activate the device every day during the 6 months of follow-up.⁴

Overall, use of the device was shown to be safe and feasible, with no device explantations, device-relation infections, nor pain reported during stimulation. Two patients reported mild, transient discomfort. Implantation of the device added approximately 45 minutes to the RARP procedure.

Patients in the study also showed promising early functional outcomes, with 9 of 10 patients regaining potency following prostatectomy. Many patients in the trial were also able to resume unaided sexual intercourse.

Based on these results, Comphya announced plans to initiate a larger controlled clinical trial of the CaverSTIM device following completion of the pilot studies. The larger scale trial would build on these initial studies by further assessing the safety, tolerability, and efficacy of the device in restoring erectile function post-prostatectomy. The company also noted that use of the CaverSTIM device is being explored for other neurogenic causes of erectile dysfunction, such as spinal cord injury.

Rationale for neurostimulation

Investigators also published a scientific review outlining the rationale for implantable neurostimulation for managing post-prostatectomy erectile dysfunction. According to the authors, this approach is backed by 150 years of research showing erection responses following electrical stimulation.

Electrical neurostimulation of the penis, they explain, targets the penile-nerve supply that may be impaired by disease, injury, or aging, thus promoting authentic nerve functioning. The authors argue that this approach may address limitations of existing treatments by acting as a restorative therapy rather than a compensatory one.

“The strength of this technology lies in its alignment with our understanding of erectile neurophysiology,” concluded co-author Rodrigo Fraga, PhD, COO of Comphya, in the news release. “We are grateful to Dr. [Arthur] Burnett, and the other co-authors for advancing this work, which we believe will represent a cornerstone for the field of neurostimulation and erectile dysfunction management. By stimulating the cavernous nerves at a time when injury is predictable, we may be able to promote neural rehabilitation and facilitate functional recovery rather than accepting postoperative erectile dysfunction as inevitable. While larger controlled trials are required, the early data strongly support continued clinical investigation.”

REFERENCES

1. Costello AJ, Dundee PE, Crowe HR, et al. First in man study of cavernous nerve neurostimulator for erectile function preservation. BJU Int. 2026;137(2):264-268. doi:10.1111/bju.70066

2. Burnett AL, Sturny MN, Costello AJ, et al. Implantable pelvic neurostimulators to restore erectile function: from concept to practice. Nat Rev Urol. 2026. doi:10.1038/s41585-025-01116-5

3. Comphya announces publication of CaverSTIM first-in-man clinical study in BJUI and scientific review in Nature Urology. News release. Comphya SA. January 21, 2026. Accessed January 21, 2026. https://www.globenewswire.com/news-release/2026/01/21/3222558/0/en/Comphya-Announces-Publication-of-CaverSTIM-First-in-Man-Clinical-Study-in-BJUI-and-Scientific-Review-in-Nature-Urology.html

4. Safety and tolerability of a novel implantable device for the treatment of erectile dysfunction. ClinicalTrials.gov. Last updated October 16, 2024. Accessed January 21, 2026. https://clinicaltrials.gov/study/NCT05650866