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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04012437
Enrollment
40
Registered
2019-07-09
Start date
2019-07-01
Completion date
2019-12-30
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Masturbation, Medical Device, Premature Ejaculation

Keywords

Premature ejaculation, IELT, Medical device

Brief summary

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

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.

Interventions

DEVICESphincter Control Training (SCT)

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

Sponsors

Hospital Virgen del Alcazar de Lorca
CollaboratorUNKNOWN
Instituto Sexológico Murciano
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

A simple blind: The subjects do not know whether they are receiving an experimental treatment or a control treatment.

Intervention model description

Randomized control trial

Eligibility

Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
IELT FOLD INCREASE10 weeksThe 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

MeasureTime frameDescription
PEDT10 weeksThe 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026