Transcutaneous perineal electrical stimulator improves intravaginal ejaculatory latency time

The IELT significantly increased by 3.22-fold in the Mini-patch device group, compared with the sham group (P = .0047).

The Mini-patch, an on-demand transcutaneous perineal electrical stimulator, significantly increased intravaginal ejaculatory latency time (IELT) in men experiencing premature ejaculation (PE), according to study results presented at the 2022 American Urological Association (AUA) Annual Meeting.1

Geometric mean IELT at baseline was 67 seconds, which significantly increased to 123 seconds (P < .0001) in the active device group, compared with 63 seconds at baseline, which increased to just 81 seconds (P = .1653) in the sham device group.

The IELT significantly increased by 3.22-fold in the Mini-patch device group, compared with the sham group (P = .0047).

Moreover, overall geometric mean time fold increases of IELT in the active device group compared with the sham group were 1.7 (95% CI, 1.5-2.1), compared with 1.2 (95% CI, 1.0-1.6).

No serious adverse events (AEs) were reported.

Because available treatments for PE can have limited efficacy and low adherence, the investigators aimed to evaluate the feasibility, safety, and efficacy of the Mini-patch.

In the bi-center, international, prospective, randomized, double-blind, 2-arm, sham- controlled, clinical study, patients were randomized 2:1 to receive the active (n = 34) or sham (n = 17) device.

Eligibility criteria included IELT values and medical/sexual history.

Safety was evaluated by the incidence of treatment-emergent AEs, and efficacy was evaluated through Clinical Global Impression of Change (CGIC) scores, Premature Ejaculation Profile (PEP) questionnaire outcomes, and the Mini-patch safety profile.

Device efficacy by mean fold change in geometric mean IELT served as the study’s primary end point.

“Mini-patch has the potential to become a leading on-demand, noninvasive, and drug-free treatments for PE,” the investigators concluded.

Reference

1. Shechter A, Mondaini N, Serefoglu EC, et al. Novel on-demand treatment for lifelong premature ejaculation using transcutaneous perineal mini-patch stimulator. J Urol. 207(55);5S:e1045. doi:JU.0000000000002670.11.