Premature EjaculationNCT04012437
Efficacy of App and Electronic Device in the Treatment of Premature Ejaculation
A study of Premature Ejaculation and Masturbation, run by Instituto Sexológico Murciano at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Premature Ejaculation, Masturbation, Medical Device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Premature Ejaculation, Masturbation, Medical Device
- Being tested
- Sphincter Control Training (SCT)
- Keywords
- Premature ejaculation, IELT, Medical device
- Medical subject headings
- Premature Ejaculation, Masturbation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Sphincter Control Training (SCT)Behavioural
The SCT consists of 4 different exercises and an educational session into a app using a masturbation electronic aid device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sphincter Control Training (SCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Sexológico Murciano
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Virgen del Alcazar de Lorca
- Responsible party
- Principal investigator, Jesus Eugenio Rodríguez Martínez, Instituto Sexológico Murciano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012437
- Sponsor's protocol ID
- ISM-SCT-2019-01
- Status last verified
- Apr 2020
- First submitted
- 4 Jul 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphincter Control Training Program Using a App and Electronic Medical Device in the Treatment of Premature Ejaculation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04012437
- Acronym / sponsor ID
- ISM-SCT-2019-01
- Conditions
- Premature Ejaculation, Masturbation, Medical Device
- Keywords
- Premature ejaculation, IELT, Medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Sexológico MurcianoUniversity, hospital or other
- Collaborators
- Hospital Virgen del Alcazar de Lorca
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Sphincter Control Training (SCT).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. |
| Control | Active comparator | Behavioral: Sphincter Control Training (SCT).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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Experimental |
| Sphincter Control Training (SCT)The SCT consists of 4 different exercises and an educational session into a app using a masturbation electronic aid device | Behavioural | Control |
Primary outcome
IELT FOLD INCREASE
Time frame: 10 weeks
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)
1 secondary outcome
PEDT
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Premature Ejaculation and Masturbation, run by Instituto Sexológico Murciano at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IELT FOLD INCREASE (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.