A Randomized, Controlled Study of the Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device
| Registry | NCT03304808 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 35 (Actual) |
| Sponsor | Instituto Sexológico Murciano (Other); collaborators: Universidad Miguel Hernandez de Elche |
| Conditions | Premature Ejaculation, Cognitive-Behavior Treatment, Masturbation Aid Device |
| Interventions | Exercise Programme +device+ lubricant, Exercise Programme + lubricant (Device, behavioral) |
| Dates | start 2017-10-01, primary completion 2017-10-30, completion 2017-12-01, first posted 2017-10-09, last updated 2018-07-09 |
| Locations | 1 site in Spain |
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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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| device | Experimental | Device: Exercise Programme +device+ lubricant | |
| behavioral | Active comparator | Behavioral: Exercise Programme + lubricant | |
| waiting list | No intervention |
Sex: Male, ages: 18 Years to any, accepts healthy volunteers
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).
| Facility | City | Country | Status |
|---|---|---|---|
| Jesús Rodríguez | Murcia | Spain |