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

Primary Purpose

Premature Ejaculation, Masturbation, Medical Device

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sphincter Control Training (SCT)
Sphincter Control Training (SCT)
Sponsored by
Instituto Sexológico Murciano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring Premature ejaculation, IELT, Medical device

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept 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).

Sites / Locations

  • Jesús Rodríguez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm 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.

.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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
July 4, 2019
Last Updated
April 12, 2020
Sponsor
Instituto Sexológico Murciano
Collaborators
Hospital Virgen del Alcazar de Lorca
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1. Study Identification

Unique Protocol Identification Number
NCT04012437
Brief Title
Efficacy of App and Electronic Device in the Treatment of Premature Ejaculation
Official Title
Sphincter Control Training Program Using a App and Electronic Medical Device in the Treatment of Premature Ejaculation: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Sexológico Murciano
Collaborators
Hospital Virgen del Alcazar de Lorca

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation, Masturbation, Medical Device
Keywords
Premature ejaculation, IELT, Medical device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
Participant
Masking Description
A simple blind: The subjects do not know whether they are receiving an experimental treatment or a control treatment.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Sphincter Control Training (SCT)
Intervention Description
The SCT + device consists of 8 different exercises and an educational session into a app using a masturbation electronic aid device
Intervention Type
Behavioral
Intervention Name(s)
Sphincter Control Training (SCT)
Intervention Description
The SCT consists of 4 different exercises and an educational session into a app using a masturbation electronic aid device
Primary Outcome Measure Information:
Title
IELT FOLD INCREASE
Description
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 Outcome Measure Information:
Title
PEDT
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Jesús Rodríguez
City
Murcia
ZIP/Postal Code
30007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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