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CompletedNCT04012437Updated Apr 14, 2020

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

An interventional study of Sphincter Control Training (SCT) and Sphincter Control Training (SCT) in Premature Ejaculation, Masturbation and Medical Device, sponsored by Instituto Sexológico Murciano. Completed at 1 site in Spain. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-04-14.

Sponsored by Instituto Sexológico Murciano · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Premature Ejaculation
  • Masturbation
  • Medical Device

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Keywords

  • Premature ejaculation
  • IELT
  • Medical device
03

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's enrollment of 40 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

Instituto Sexológico Murciano is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • DeviceSphincter Control Training (SCT)

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

  • BehavioralSphincter Control Training (SCT)

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 10 weeks

Secondary outcomes

  1. 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

    Time frame: 10 weeks

07

Study locations

1 site
  • Jesús Rodríguez
    Murcia, 30007, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04012437
Lead sponsor
Instituto Sexológico Murciano
Collaborators
Hospital Virgen del Alcazar de Lorca
Responsible party
Jesus Eugenio Rodríguez Martínez (Director of Research Area, Instituto Sexológico Murciano) — Principal investigator
First posted
Jul 9, 2019
Start date
Jul 1, 2019
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019
Last update
Apr 14, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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