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

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.

Study Overview

• Status: Completed
• Conditions: Premature Ejaculation; Medical Device; Masturbation
• Intervention / Treatment: Device: Sphincter Control Training (SCT); Behavioral: Sphincter Control Training (SCT)

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30007
    • Jesús Rodríguez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto Sexológico Murciano
• Collaborators: Hospital Virgen del Alcazar de Lorca

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 12, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Medical device; Premature ejaculation; IELT
• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: ISM-SCT-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No