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

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 dev...

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Bibliographic Details
Published in:	PloS one Vol. 16; no. 9; p. e0257284
Main Authors:	Rodríguez, Jesús E, Picazo, Jose A, Marzo, Juan C, Piqueras, José A, Reina, Leandro, Hidalgo, Guillermo, Tornero, Guillermo
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 21-09-2021 Public Library of Science (PLoS)
Subjects:	Adult Anal Canal - physiology Biology and Life Sciences Care and treatment Clinical trials Cognitive Behavioral Therapy - methods Coitus - physiology Computer and Information Sciences Design Double-Blind Method Ejaculation Ejaculation - physiology Engineering and Technology Evaluation Health psychology Health services Hospitals Humans Hypotheses Latency Male Masturbation Medical equipment Medicine and Health Sciences Middle Aged Physiological apparatus Premature ejaculation Premature Ejaculation - psychology Premature Ejaculation - therapy Research and Analysis Methods Side effects Social Sciences Sociodemographics Sphincter Training Treatment Outcome Urethra - physiology Urology Young Adult Spain
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23 Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Rodríguez is a consultant of New Wellness Concept and has not received compensation for this work; he is acting as an expert witness. Marzo is the thesis director of Rodríguez and he is acting as an expert witness and Piqueras is the thesis codirector of Rodríguez and he is acting as an expert witness. Picazo, Reina,Hidalgo y Tornero has no conflict of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
ISSN:	1932-6203 1932-6203
DOI:	10.1371/journal.pone.0257284