A wearable patch that delivers electrical stimulation to the perineum may postpone premature ejaculation, according to research presented at the 2022 annual meeting of the American Urological Association. The disposable device appears to work by helping men contract the muscles in the pelvic floor, allowing them to postpone climax.
Among 34 men with a lifelong history of premature ejaculation, average intravaginal ejaculatory latency time — the time from vaginal penetration to ejaculation — increased from about 67 seconds at baseline to 123 seconds when they used the device.
Another 17 participants received a sham treatment — stimulation they could feel but that did not activate muscles. In this group, time to ejaculation increased from 63 seconds to 81 seconds.
The longer duration with active treatment was statistically significant (P < .0001), whereas the increase in the control group was not (P = .1653), said Ege Can Serefoglu, MD, a researcher at Biruni University, Istanbul, Turkey, and editor-in-chief of the International Journal of Impotence Research.
Serefoglu is a member of the scientific advisory board for Virility Medical, a company in Hod Hasharon, Israel that is developing the stimulator. Marketed as vPatch, the device is expected to be available in 2023, Serefoglu said. It was cleared by the US Food and Drug Administration in November and has CE-mark approval in Europe, according to the company.
vPatch is a wearable device that delivers electrical stimulation to the perineum with the aim of postponing premature ejaculation. The device appears to work by helping men contract the muscles in the pelvic floor, allowing them to postpone climax.
Common Problem, Limited Options
Research shows that 20%-30% of men are not happy with their time to ejaculation, Serefoglu said.
The International Society for Sexual Medicine defines premature ejaculation as ejaculation which always or almost always occurs within about 1 minute of penetration, the patient is unable to delay this occurrence, and the condition causes personal distress.
“Unfortunately, in spite of its high prevalence we do not really have any satisfying treatment options,” Serefoglu said.
Topical anesthetics may be used to decrease the sensitivity of the glans penis, and selective serotonin reuptake inhibitors may help delay ejaculation. But these options have limited efficacy and low adherence, he said.
Preclinical studies have shown that injection of botulinum toxin into the bulbospongiosus muscles is associated with a dose-dependent increase in ejaculation latency in rats.
Data on ClinicalTrials.gov show that this approach also may increase ejaculation latency in men, Serefoglu said. Although investigators found no safety concerns, drugmaker Allergan made a strategic business decision to stop developing this treatment approach, according to the registration entry for the study.
The idea for vPatch came from researchers wondering if instead of paralyzing the muscles with botulinum toxin, they used electrical stimulation to cause contraction of those muscles, Serefoglu said. A smaller proof-of-concept study demonstrated the feasibility and safety of this technique.
To further assess the safety and efficacy of a transcutaneous perineal electrical stimulator for the treatment of premature ejaculation, investigators conducted the randomized, double-blind, sham-controlled trial at Rambam Medical Centre, Haifa, Israel, and Villa Donatello Clinic, Florence, Italy.
The trial included males with premature ejaculation aged 18-60 years. Their female partners measured IELT using a stopwatch during four sexual intercourse sessions before treatment, and four times on treatment, at home.
In addition to the increased time to ejaculation, perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty related to ejaculation all significantly improved with vPatch, the researchers found.
Of participants who received active treatment, 73.5% reported a subjective sense of improvement vs 41.2% of the control group.
No serious adverse events were observed, Serefoglu reported. Potential adverse reactions include redness, discomfort, and localized pain, according to the company’s website.
Men should not use vPatch if they have been diagnosed with pelvic cancer, or if they have an implanted electronic device, diabetes with peripheral neuropathy, or perineal dermatologic diseases, irritations, or lesions. Other precautions include avoiding use of the vPatch in water or humid environments. The device has not been tested on use with a pregnant partner.
The disposable patches are meant for one-time use. “The miniaturized perineal stimulation device may become an on-demand, drug-free therapeutic option,” Serefoglu said.
Combining electrical stimulation with other treatment approaches may provide additional benefit, said Bradley Schwartz, DO, professor and chairman of urology at Southern Illinois University School of Medicine in Springfield, who moderated the session at the AUA meeting at which the results of the study were presented.
“You go from 1 to 2 minutes just with this device,” Schwartz said. “If you went from 2 to 3 minutes, you would essentially be tripling their pleasure or their time, which might make a significant difference.”
Serefoglu agreed that combining the stimulator with other treatment approaches such as topical anesthetics could increase patient satisfaction.
Co-moderator Kelly Healy, MD, assistant professor of urology at Columbia University Medical Center in New York City, highlighted a direction for future research: examining outcomes according to different types of relationships, as well as partner satisfaction.
“That is a perfect question that should also be considered in the future trials,” Serefoglu said. “This was mainly focused on the man’s satisfaction. But men are trying to delay their ejaculation to satisfy their partner.”
Serefoglu is on the scientific advisory board for Virility Medical, which sponsored the study. Healy had no disclosures. Schwartz disclosed ties to Cook Medical.
American Urological Association 2022 annual meeting: Abstract LBA02-11. Presented May 15, 2022.
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