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

Instituto Sexológico Murciano

Status: Completed

Conditions: Masturbation; Medical Device; Premature Ejaculation

Treatments: Behavioral: Sphincter Control Training (SCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04012437

ISM-SCT-2019-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Experimental

Experimental group

Description:

.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.

Control

Active Comparator group

Description:

.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.

Treatment:

Behavioral: Sphincter Control Training (SCT)

Behavioral: Sphincter Control Training (SCT)