Premature EjaculationNCT03304808
Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0
A study testing Exercise Programme +device+ lubricant and Exercise Programme + lubricant in people with Premature Ejaculation and Cognitive-Behavior Treatment, run by Instituto Sexológico Murciano at 1 site in Spain.
Trial summary
The present study included 57 patients ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ≥11. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation, Cognitive-Behavior Treatment, Masturbation Aid Device
- What is being tested?
- Exercise Programme +device+ lubricant and Exercise Programme + lubricant
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to 1 Dec 2017
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be heterosexual males
- To be in a stable monogamous, sexual relationship with a female partner for at least 6 months,
- Must score = 11 in the Premature Ejaculation Diagnostic Tool (PEDT).
- Must have a self-estimated average intravaginal ejaculatory latency time (IELT) of <2 min. -Must be in good general health with no clinically significant abnormalities as determined by medical history and clinical lab results.
Who cannot join
- To suffer an alteration or mental disorder according to the criteria of the DSM-IV.
- History of alcohol abuse and dependence.
- Do not to consume medication, drugs of recreative use or alcohol (except for caffeine or nicotine/tobacco).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study of the Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device
The present study included 57 patients ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ≥11.
Subjects were randomized to an experimental group that used the device with exercise programme (n=18) a first control group that only used the exercise programme (n=17) and a wait-list control group (n=22).
As a main outcome measure used stopwatch-measured average IELT, Premature Ejaculation Profile (PEP), and the Golombok-Rust Inventory of Sexual Satisfaction (GRISS).
- Being tested
- Exercise Programme +device+ lubricant, Exercise Programme + lubricant
- Keywords
- premature ejaculation, cognitive-behavior, treatment, device
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Programme +device+ lubricantDevice
A first line treatment for the PE of a new 7 weeks exercise programme to control male orgasm using a masturbation aid device in a variation of the classical stop-start technique first introduced by Semans in 1956.
Four exercise:
- Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area .
- Star and Stop to identify the tension and try to reduce this tension, on the pelvic floor muscles pay special attention to the anal sphincter.
- Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating
- Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating
Exercise Programme + lubricantBehavioural
A first line treatment for the PE of a new 7 weeks exercise programme to control male orgasm using a masturbation aid device in a variation of the classical stop-start technique first introduced by Semans in 1956.
Four exercise:
- Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area .
- Star and Stop to identify the tension and try to reduce this tension, on the pelvic floor muscles pay special attention to the anal sphincter.
- Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating
- Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating
| Study group | Role | What they receive |
|---|---|---|
| device | Experimental | Not described Receives: Device: Exercise Programme +device+ lubricant |
| behavioral | Active comparator | Not described Receives: Behavioral: Exercise Programme + lubricant |
| waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
IELT FOLD INCREASE
fold changes are defined directly in terms of ratios.If the initial value is A and the final value B, the fold change is defined as B/A
Measured: 7 weeks
Secondary outcomes (1)
Premature Ejaculation Profile (PEP)
proportion of patients who achieved criteria for clinical benefit, defined as achieving a two-category or greater increase in the change in control over ejaculation and level of satisfaction with intercourse, and a one-category or greater increase in the change in ejaculation-related distress and degree of interpersonal difficulty.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 Oct 2017
- Primary completion30 Oct 2017
- Study completion1 Dec 2017
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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Sexológico Murciano
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304808
- Sponsor's protocol ID
- ISMSEXOLOGIA
- Status last verified
- Jul 2018
- First submitted
- 30 Mar 2017
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of the Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device
- ClinicalTrials.gov ID
- NCT03304808
- Acronym / sponsor ID
- ISMSEXOLOGIA
- Keywords
- premature ejaculation, cognitive-behavior, treatment, device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Instituto Sexológico MurcianoUniversity, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 9 Oct 2017 (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.
The present study included 57 patients ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ≥11.
Subjects were randomized to an experimental group that used the device with exercise programme (n=18) a first control group that only used the exercise programme (n=17) and a wait-list control group (n=22).
As a main outcome measure used stopwatch-measured average IELT, Premature Ejaculation Profile (PEP), and the Golombok-Rust Inventory of Sexual Satisfaction (GRISS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| device | Experimental | Device: Exercise Programme +device+ lubricant |
| behavioral | Active comparator | Behavioral: Exercise Programme + lubricant |
| waiting list | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be heterosexual males
- To be in a stable monogamous, sexual relationship with a female partner for at least 6 months,
- Must score = 11 in the Premature Ejaculation Diagnostic Tool (PEDT).
- Must have a self-estimated average intravaginal ejaculatory latency time (IELT) of <2 min. -Must be in good general health with no clinically significant abnormalities as determined by medical history and clinical lab results.
Key exclusion criteria (3 listed)
- To suffer an alteration or mental disorder according to the criteria of the DSM-IV.
- History of alcohol abuse and dependence.
- Do not to consume medication, drugs of recreative use or alcohol (except for caffeine or nicotine/tobacco).
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 |
|---|---|---|
| Exercise Programme +device+ lubricantA first line treatment for the PE of a new 7 weeks exercise programme to control male orgasm using a masturbation aid device in a variation of the classical stop-start technique first introduced by Semans in 1956. Four exercise: 1. Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area . 2. Star and Stop to identify the tension and try to reduce this tension, on the pelvic floor muscles pay special attention to the anal sphincter. 3. Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating 4. Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating | Device | device |
| Exercise Programme + lubricantA first line treatment for the PE of a new 7 weeks exercise programme to control male orgasm using a masturbation aid device in a variation of the classical stop-start technique first introduced by Semans in 1956. Four exercise: 1. Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area . 2. Star and Stop to identify the tension and try to reduce this tension, on the pelvic floor muscles pay special attention to the anal sphincter. 3. Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating 4. Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating | Behavioural | behavioral |
Primary outcome
IELT FOLD INCREASE
Time frame: 7 weeks
fold changes are defined directly in terms of ratios.If the initial value is A and the final value B, the fold change is defined as B/A
1 secondary outcome
Premature Ejaculation Profile (PEP)
Time frame: 7 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 9 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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 testing Exercise Programme +device+ lubricant and Exercise Programme + lubricant in people with Premature Ejaculation and Cognitive-Behavior Treatment, 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 3 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 9 Jul 2018. 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: 7 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 9 Jul 2018.