Efficacy of App and Electronic Device in the Treatment of Premature Ejaculation

Study Overview
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Brief Summary
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Randomized control trial to determine if we can produce increases in the IELT using a new masturbator electronic in subjects with premature ejaculation in combination with a exercise app, producing improvements in the quality and satisfaction of the sexuality of the patient.

Detailed Description
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This project of research will use one experimental groups, It will manage the affairs the therapy sphincter control training (SCT) into app combined with the external device called Myhixel I .Experimental groups will receive therapy with the protocol of exercises SCT. The main measure will be the fold increase (FI) of the IELT, which was calculated using the geometric mean of post-treatment IELTs (period B) divided by the geometric mean of pre-treatment IELTs (period A): FI = (geometric mean of IELT_7wk)/(geometric mean of PRE_IELT) The efficiency on the EP will see (IELT) reflected in an increase in the times of latency of intravaginal ejaculation and in punctuations of subjective perception, of the therapy on the line base. The subjects that will be born in mind will be all the interested parties in informing that their answer to the campaign of national advertising that will be started. The duration of the treatment will be 8 weeks during which a series of exercises app will be practised usin the masturbation device Myhixel I. The material used in the research will be innocuous and his responsible use does not produce adverse reactions of interest.

Official Title
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Sphincter Control Training Program Using a App and Electronic Medical Device in the Treatment of Premature Ejaculation: Randomized Controlled Trial

Conditions
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Premature Ejaculation, Masturbation, Medical Device

Intervention / Treatment
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* Device: Sphincter Control Training (SCT)
* Behavioral: Sphincter Control Training (SCT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 18 years. Being in a heterosexual relationship for at least the last 6 months. Having a score of >11 on the Premature Ejaculation Diagnostic Tool (PEDT). Having a self-reported IELT ≤2 minutes. Exclusion Criteria: A history of alcohol abuse or dependence. Having received medication or psychological treatment for PE in the last 6 months. Having diabetes. The regular use of recreational drugs (except tobacco and caffeine).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>.The groups completed Sphincter Control Training over 8 weeks. The SCT consists of 8 different exercises into a mobile app and an educational videos. Its objective is to provide patients with greater knowledge, awareness, and control of the external urethral sphincter. The groups use of a masturbation aid device called Myhixel I from the spanish company New Wellness Concept SL. | Device: Sphincter Control Training (SCT)<br>* The SCT + device consists of 8 different exercises and an educational session into a app using a masturbation electronic aid device<br>|
| Active Comparator: Control<br>.The groups completed Sphincter Control Training over 8 weeks. The SCT consists of 8 different exercises into a video tutorial and an educational videos. Its objective is to provide patients with greater knowledge, awareness, and control of the external urethral sphincter. | Behavioral: Sphincter Control Training (SCT)<br>* The SCT consists of 4 different exercises and an educational session into a app using a masturbation electronic aid device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IELT FOLD INCREASE | The main measure will be the fold increase (FI) of the IELT, which was calculated using the geometric mean of post-treatment IELTs (period B) divided by the geometric mean of pre-treatment IELTs (period A): FI = (geometric mean of IELT_7wk)/(geometric mean of PRE_IELT) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEDT | The test-retest reliability of the PEDT is .82, and all items discriminate in a statistically significant way between patients with PE and without PE, with a cut-off score for the diagnosis | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature ejaculation, IELT, Medical device