Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Controlled Study of the Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device

Conditions
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Premature Ejaculation, Cognitive-Behavior Treatment, Masturbation Aid Device

Intervention / Treatment
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* Device: Exercise Programme +device+ lubricant
* Behavioral: Exercise Programme + lubricant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: device<br> | Device: Exercise Programme +device+ lubricant<br>* 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<br>|
| Active Comparator: behavioral<br> | Behavioral: Exercise Programme + lubricant<br>* 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<br>|
| No Intervention: waiting list<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature ejaculation, cognitive-behavior, treatment, device