A novel therapy for premature ejaculation: transcutaneous functional electrical stimulation-results of a pioneer study
Shechter, A1; Serefoglu, E2; Gollan, T2; Springer, S2; Meiry, G2; Appel, B2; Gruenwald, I2
1: Israel; 2: Israel
Objectives: To evaluate the safety and efficacy of Transcutaneous functional electrical stimulation (TFES) for the treatment of Premature Ejaculation (PE).
Materials and methods: Our preliminary safety study (n=19) demonstrated that applying TFES to the perineal region is safe. In the present study, we included 23 men aged 20-60 that complained of PE. On the first visit of this prospective, single-blinded, self-controlled study, we alternately delivered either TFES or sham treatment to the perineum, based on the enrollment order. For stimulation, we used a commercial neuro-muscular electrical stimulation device. The alternating second treatment was given to the same subject after a minimal period of one week. In order to determine the intensity threshold for muscle contraction, we gradually increased TFES intensity. Patients were instructed to inform the investigator upon first sensation of a convenient muscle contraction in the stimulated area, after which we applied this individual intensity-threshold during the study.
The patients were left alone in a silent room to masturbate and, using a stopwatch, to measure their Masturbation Ejaculatory Latency Time (MELT), measured between full erection and ejaculation. Patients filled-out safety questionnaires after each visit and on each of the three following days.
Results: Twenty-three patients, aged 22-54 year old (average – 37.5) entered the study. One patient withdrew due to personal reasons and two were disqualified, one due to inability to reach erection and one due to ejaculation without erection. Twenty patients completed the study. Ejaculation time was compared between groups using a repeated measures ANOVA model, where MELT is modeled as a function of group, period and sequence, with the sequence nested within subject ID as the repeated measurement. In 17 out of the 20 patients (85%), TFES considerably prolonged MELT. Results show significant improvements compared to sham, where overall MELT increased 3.5-fold (p=0.0009).
Conclusions: We demonstrated a significant increase in MELT in self-reported PE patients using TFES. Miniaturized perineal on-demand stimulation device which can be used in a home setting during sexual intercourse, has the potential to become the first-line treatment for PE.
Work supported by industry: yes, by Virility Medical (industry funding only - investigator initiated and executed study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.Go Back