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

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.

SUBMITTER: Rodriguez JE

PROVIDER: S-EPMC8454929 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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

Rodríguez Jesús E JE Picazo Jose A JA Marzo Juan C JC Piqueras José A JA Reina Leandro L Hidalgo Guillermo G Tornero Guillermo G

PloS one 20210921 9

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) ...[more]

PMID: 34547013

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Project description:IntroductionCurrent evidence suggests that Cognitive Behavioral therapy (CBT) has a limited role in the contemporary management of premature ejaculation (PE).AimThe aim of this study was to determine the efficacy of a new CBT for the PE called Sphincter Control Training (SCT) in combination with a masturbation aid device.MethodsThe present study included 35 patients' that met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ≥11. Participants completed all phases of a randomized controlled clinical study with a parallel group design, which was approved by the Ethical Committee of the Hospital Morales Meseguer of Murcia (Spain).The two treatment groups completed SCT over 7 weeks. The SCT consists of four different exercises and an educational session. Its objective is to provide patients with greater knowledge, awareness, and control of the external urethral sphincter. The only difference between groups was the use of a masturbation aid device called Flip Zero (TFZ-001) from the Japanese company Tenga Co., Ltd.OutcomesThe main measure was the "fold increase" (FI) of the IELT, which was calculated using the geometric mean pre-treatment and post-treatment. In addition, Premature Ejaculation Profile PE was used as a secondary measure.ResultsThe geometric mean of the measurements corresponding to the 7 weeks of treatment was calculated, and both groups were compared by means of an ANCOVA test, finding a statistically significant difference (F: 10.51, 1; p = .003) in the increase experienced by subjects in the group with the device (GWD) mean = 166.63, SD = 106.54) compared with that experienced by subjects in the group without device (GWtD) (mean = 86.99, SD = 59.98).Using Student's t-test, the Fold increase (FI) corresponding to both groups were compared. The results showed statistically significant differences (p = .008) between the measurements corresponding to the GWtD (1.38 (0.50)) and those relative to the GWD (2.69 (1.81)).Clinical implicationsThe FI in the GWD at the end of the trial allow us to consider this new CBT as a potential and viable PE treatment alternative. No side effects were observed in either treatment group and it required little therapeutic input and no partner involvement.Strengths & limitationsThe main limitation of this study is the lack of a 3- to 6-month follow-up of the treatment and placebo control.ConclusionsThis SCT exercise program combined with the use of a masturbation device shows promise because has numerous advantages in relation to current recommended treatments in patients with PE.

Project description:BackgroundThe aim of this study is to compare the results of stop-start technique with stop-start technique together with sphincter control training applied in the treatment of premature ejaculation.MethodsThis research was conducted as a pre-test post-test quasi-experimental study. The sample of the study consisted of 80 men. The study was conducted on men who applied to the urology outpatient clinic of LIV Hospital, a prıvate hospital, in Gaziantep, Turkey, between 01 October 2021 and 01 March 2022. "Personal Information Form", "Intravaginal Ejaculation Latency Time (IELT)", "Fold Increase Intravaginal Ejaculation Latency Time (F-IELT)" "Premature Ejaculation Diagnostic Tool (PEDT) Questionnaire" and "Arabic Index Premature Ejaculation (AIPE)" were used as the data collection tools. Behavioral therapy, consisting of a total of 6 sessions, was applied once every two weeks, with each session lasting for 45 minutes. After 3rd and 6th months from the beginning of the application, the data collection tools were applied again. "Stop-Start Technique (Group A)" and "Stop-Start Technique and Sphincter Control Training (Group B)" were used in the treatment.ResultsIn both groups, the IELT and AIPE values after 3rd and 6th months from the beginning of the application were statistically higher than those obtained before (p<0.05). IELT and AIPE values increased more in Group B than Group A (p<0.05). F-IELT values after 6th months from the beginning of the application were found to be statistically significant with a low level of effect size than those obtained before (p<0.05, Cohen's d = 0.027). In both groups, the PEDT values in the 3rd and 6th months after the application were statistically lower than those seen before (p<0.05). PEDT value decreased more in Group B than Group A (p<0.05). The differences between the two groups' IELT (Cohen's d = 0.011), AIPE (Cohen's d = 0.044), and PEDT (Cohen's d = 0.066) values in the 3rd month after the application and IELT (Cohen's d = 0.025), AIPE (Cohen's d = 0.048), and PEDT (Cohen's d = 0.024) values in the 6th month after the application were found to be clinically weak.ConclusionsIt was determined that the stop-start technique given to men with premature ejaculation increased the time spent in the vagina and eliminated the problem of premature ejaculation. It was determined that the stop-start technique in combination with sphincter control training were more effective than the stop-start technique alone.

Dataset Information

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

Publications

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

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