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

NCT04012437 | Completed

• 1 other identifier: ISM-SCT-2019-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ejaculation; Masturbation; Medical Device

Keywords

Premature ejaculation; IELT; Medical device

Outcome Measures

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)

  10 weeks

Secondary Outcomes (1)

• PEDT

  10 weeks

Study Arms (2)

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)

Control

ACTIVE COMPARATOR

.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

Sphincter Control Training (SCT) DEVICE

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

Experimental

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Sexológico Murciano: lead
• Hospital Virgen del Alcazar de Lorca: collaborator

Study Sites (1)

Jesús Rodríguez

Murcia, 30007, Spain

Location

MeSH Terms

Conditions

Premature Ejaculation; Masturbation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A simple blind: The subjects do not know whether they are receiving an experimental treatment or a control treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Area

Model Details: Randomized control trial

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 9, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)