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

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ClinicalTrials.gov Identifier: NCT03304808
Recruitment Status : Completed
First Posted : October 9, 2017
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
Universidad Miguel Hernandez de Elche
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Premature Ejaculation Cognitive-Behavior Treatment Masturbation Aid Device Device: Exercise Programme +device+ lubricant Behavioral: Exercise Programme + lubricant Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study of the Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : December 1, 2017

Arm Intervention/treatment
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:

  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

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:

  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

No Intervention: waiting list



Primary Outcome Measures :
  1. IELT FOLD INCREASE [ Time Frame: 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 :
  1. Premature Ejaculation Profile (PEP) [ Time Frame: 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.


Other Outcome Measures:
  1. Golombok Rust Inventory of Sexual Satisfaction (GRISS) [ Time Frame: 7 weeks ]
    Scale ejaculatory function



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304808


Locations
Spain
Jesús Rodríguez
Murcia, Spain, 30007
Sponsors and Collaborators
Instituto Sexológico Murciano
Universidad Miguel Hernandez de Elche

Responsible Party: Instituto Sexológico Murciano
ClinicalTrials.gov Identifier: NCT03304808     History of Changes
Other Study ID Numbers: ISMSEXOLOGIA
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto Sexológico Murciano:
premature ejaculation
cognitive-behavior
treatment
device

Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders