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

Not Applicable

Completed

• Conditions: Premature Ejaculation; Cognitive-Behavior Treatment; Masturbation Aid Device

• Registration Number: NCT03304808
• Lead Sponsor: Instituto Sexológico Murciano

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study Start: 2017-10-01
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-09
• Primary Completion: 2017-10-30
• Study Completion: 2017-12-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IELT FOLD INCREASE	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

Secondary Outcome Measures

Name	Time	Method
Premature Ejaculation Profile (PEP)	7 weeks	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.

Trial Locations

Locations (1)

Jesús Rodríguez; 🇪🇸 Murcia, Spain