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

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012437
• Other study ID #: ISM-SCT-2019-01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2020
• Source: Instituto Sexológico Murciano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

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).

Related Conditions & MeSH terms

• Masturbation
• Medical Device
• Premature Birth
• Premature Ejaculation

Intervention

Device:
• 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

Behavioral:
• Sphincter Control Training (SCT)
The SCT consists of 4 different exercises and an educational session into a app using a masturbation electronic aid device

Locations

Country	Name	City	State
Spain	Jesús Rodríguez	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Sexológico Murciano	Hospital Virgen del Alcazar de Lorca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IELT FOLD INCREASE	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)	10 weeks
Secondary	PEDT	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	10 weeks