Efficacy of Sphincter Control Training and medical device in the treatment of premature ejaculation: A multicenter randomized controlled clinical trial

PLoS One. 2021 Sep 21;16(9):e0257284. doi: 10.1371/journal.pone.0257284. eCollection 2021.

Abstract

A new line of treatment for premature ejaculation (PE) based on the use of masturbation aid device in combination with behavioral techniques has emerged in recent years. We report a multicenter randomized clinical trial with a parallel group design to determine the effectiveness of an electronic device called Myhixel I© in the treatment of PE. Forty patients who met the criteria for the diagnosis of lifelong PE, were assigned to two treatment groups completed the Sphincter control training (SCT) program in eight weeks. The only difference between groups was the use of the device. The main measure was the "fold increase" (FI) of the intravaginal ejaculatory latency time (IELT). The geometric means of IELT show, at the end of the treatment at week 8, a superiority of the device group. The mean FI 4.27 (SD 2.59) at the end of treatment for the device group was clearly higher than obtained in the previous clinical trial, in which a specific medical device was not used. No side effects were observed and it required little therapeutic input and no partner involvement. The SCT program in combination with the Myhixel I© is an effective treatment for PE.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anal Canal / physiology*
  • Cognitive Behavioral Therapy / methods*
  • Coitus / physiology
  • Double-Blind Method
  • Ejaculation / physiology*
  • Humans
  • Male
  • Masturbation
  • Middle Aged
  • Premature Ejaculation / psychology
  • Premature Ejaculation / therapy*
  • Treatment Outcome
  • Urethra / physiology*
  • Young Adult

Grants and funding

The 50% of the financing of the study will be chargeable to the area of research of the MIS, whereas other one 50% will be financed on the part of the NEW WELLNESS CONCEPT SL. This 50% is about the source of material consists in 30 MYHIXEL I devices + 30 bottles of lubricant, so there is no existing conflict of interests.The “New Wellness Concept” is the manufacturer of the Myhixel I ® device investigated in our study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.