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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03304808
Enrollment
35
Registered
2017-10-09
Start date
2017-10-01
Completion date
2017-12-01
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive-Behavior Treatment, Masturbation Aid Device, Premature Ejaculation

Keywords

premature ejaculation, cognitive-behavior, treatment, device

Brief 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. 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).

Interventions

DEVICEExercise Programme +device+ lubricant

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: 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

BEHAVIORALExercise Programme + lubricant

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: 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

Sponsors

Universidad Miguel Hernandez de Elche
CollaboratorOTHER
Instituto Sexológico Murciano
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
IELT FOLD INCREASE7 weeksfold 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

Secondary

MeasureTime frameDescription
Premature Ejaculation Profile (PEP)7 weeksproportion 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.

Other

MeasureTime frameDescription
Golombok Rust Inventory of Sexual Satisfaction (GRISS)7 weeksScale ejaculatory function

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026