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Completed

NCT Number: NCT04012437

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

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.

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Key information

Conditions

Premature Ejaculation Behavior Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Masturbation Medical Device Mental Disorders Sexual Behavior Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jesús Rodríguez

Murcia, 30007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sphincter Control Training (SCT)

Device

The SCT + device consists of 8 different exercises and an educational session into a app using a masturbation electronic aid device

Sphincter Control Training (SCT)

Behavioral

The SCT consists of 4 different exercises and an educational session into a app using a masturbation electronic aid device

Primary outcomes

  1. IELT FOLD INCREASE

    Time frame: 10 weeks

    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)

Secondary outcomes

  1. PEDT

    Time frame: 10 weeks

    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

Sponsors and collaborators

Lead sponsor

Instituto Sexológico Murciano

Other

Collaborators

  • Hospital Virgen del Alcazar de Lorca

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2019
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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