INTRODUCTION: Premature ejaculation (PE) is a common sexual dysfunction. Treatment ranges from behavior modification to systemic and topical pharmacological treatments. Results to date have been generally inconsistent and of limited effectiveness. New avenues of therapy are needed.
AIM: To investigate the effect of extracorporeal functional magnetic stimulation (FMS) as a noninvasive treatment for men with PE.
METHODS: The NeoControl System for FMS was used in the study. Baseline assessment included: history and physical, medications, hormonal assessment and intravaginal ejaculatory latency time (IVELT) by stopwatch determination. Treatment involved a first phase of five biweekly sessions (primary outcome). Men who reported an improvement in IVELT and desired to continue were given a second identical course (secondary outcome). Outcome measures included: IVELT and a global assessment questionnaire (GAQ). The responses incorporated both the patient's perception of response together with the more objective IVELT timing and were rated as: 1. Worse: no improvement in GAQ or mean IVELT for the total number of attempts; 2. Unchanged: improvement in IVELT but the patient reported no improvement; 3. Slightly improved: increase in IVELT < 100% and a reported mild improvement and 4. Better: IVELT increase of ≥ 100% with GAQ indicating 'moderate' to 'marked' improvement.
Main outcome measures: Two primary outcome measures were considered in both treatment phases, the IVELT and the GAQ.
RESULTS: Fourteen men were treated. Their mean age was 43.7 years. Fifty-seven percent reported primary PE and 63% were circumcised. Hormone levels were normal in all. Baseline IVELT for the group was 60.6 seconds. All patients completed phase I. Of these, 50% reported no change in the GAQ although they recorded an increase in IVELT; 29% were categorized as slightly better and 14% as better. Eight men entered phase II. Of these, 3 (37.5%) were unchanged; 2 (25%) were slightly better and 3 (37.5%) were classified as better. The response in these last three has persisted for over 6 months post treatment. Both phases of the study showed a trend towards IVELT improvement, more evident at the end of phase II. However the differences did not reach statistical significance on either phase. Side effects were mild and non-treatment related.
DISCUSSION: The use of FMS is claimed to alter the spinal centers without altering cerebral neurotransmitters. Although there were some remarkable responses, our results, are not better than the purported responses to behavioral or pharmacological methodologies. There was a clear trend in IVELT improvement; however, this didn't translate into an equivalent subjective estimation by most of the subjects. This outcome dissonance might be diminished by longer/more intense regimens of treatment. The pilot nature of the study does not permit to draw solid conclusions but stimulate the search for a new therapeutic option in PE.