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

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).

Study Overview

• Status: Completed
• Conditions: Premature Ejaculation; Cognitive-Behavior Treatment; Masturbation Aid Device
• Intervention / Treatment: Device: Exercise Programme +device+ lubricant; Behavioral: Exercise Programme + lubricant

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30007
    • Jesús Rodríguez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: waiting list
Experimental: device	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
Active Comparator: behavioral	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Golombok Rust Inventory of Sexual Satisfaction (GRISS)	Scale ejaculatory function	7 weeks

Collaborators and Investigators

• Sponsor: Instituto Sexológico Murciano
• Collaborators: Universidad Miguel Hernandez de Elche

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: treatment; device; premature ejaculation; cognitive-behavior
• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: ISMSEXOLOGIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No