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

Jesús E Rodríguez,Guillermo Tornero,Leandro Reina,José A Piqueras,Jose A Picazo,Guillermo Hidalgo,Juan C Marzo,Vance Berger

doi:10.1371/journal.pone.0257284

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.

Highlights

Premature ejaculation (PE) is one of the most frequent male sexual dysfunctions [1]
Despite the recent emergence of evidence-based definitions and new PE subtypes, its true prevalence remains ambiguous [1, 2]. This ambiguity surrounding PE is in part due to the difficulty in conducting and interpreting research in the absence of a standardized universal definition that adequately encompasses the characteristics of these patients
The calculation of the Mahalanobis distances indicated the existence of two outliers, one of the GWtD and another of the GWD in the variables corresponding to fold increase” (FI)

Summary

Introduction

Premature ejaculation (PE) is one of the most frequent male sexual dysfunctions [1]. Despite the recent emergence of evidence-based definitions and new PE subtypes, its true prevalence remains ambiguous [1, 2]. This ambiguity surrounding PE is in part due to the difficulty in conducting and interpreting research in the absence of a standardized universal definition that adequately encompasses the characteristics of these patients. The evidence so far confirms the efficacy and safety of dapoxetine (LOE 1a) and other selective off-label serotonin reuptake inhibitors (SSRIs) (LOE 1a), especially paroxetine and used daily.

Methods

Results

Conclusion