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

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304808
• Other study ID #: ISMSEXOLOGIA
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: July 2018
• Source: Instituto Sexológico Murciano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 1, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive-Behavior Treatment
• Masturbation Aid Device
• Premature Birth
• Premature Ejaculation

Intervention

Device:
• Exercise 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: 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

Behavioral:
• Exercise 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: 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

Locations

Country	Name	City	State
Spain	Jesús Rodríguez	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Sexológico Murciano	Universidad Miguel Hernandez de Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Golombok Rust Inventory of Sexual Satisfaction (GRISS)	Scale ejaculatory function	7 weeks
Primary	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	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

External Links

•   campaign for recruitment website