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

NCT ID: NCT04012437

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2019-12-30

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.

Conditions

Premature Ejaculation; Masturbation; Medical Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

.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.

Group Type: EXPERIMENTAL

Sphincter Control Training (SCT)

Intervention Type: DEVICE

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

Control

.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.

Group Type: ACTIVE_COMPARATOR

Sphincter Control Training (SCT)

Intervention Type: BEHAVIORAL

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

Interventions

Sphincter Control Training (SCT)

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

Intervention Type: DEVICE

Sphincter Control Training (SCT)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Virgen del Alcazar de Lorca

UNKNOWN

Sponsor Role: collaborator

Instituto Sexológico Murciano

OTHER

Sponsor Role: lead

Responsible Party

Jesus Eugenio Rodríguez Martínez

Director of Research Area

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jesús Rodríguez

Murcia, , Spain

Countries

Spain

Other Identifiers

ISM-SCT-2019-01

Identifier Type: -

Identifier Source: org_study_id