Masturbation, Medical Device, Premature Ejaculation
Conditions
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
The SCT + device consists of 8 different exercises and an educational session into a app using a masturbation electronic aid device
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| IELT FOLD INCREASE | 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
| Measure | Time frame | Description |
|---|---|---|
| PEDT | 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 |
Countries
Spain