Abstract
To evaluate the safety and efficacy of Transcutaneous functional electrical stimulation (TFES) for the treatment of Premature Ejaculation (PE). 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.
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