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CompletedNCT03304808Updated Jul 9, 2018

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

An interventional study of Exercise Programme +device+ lubricant and Exercise Programme + lubricant in Premature Ejaculation, Cognitive-Behavior Treatment and Masturbation Aid Device, sponsored by Instituto Sexológico Murciano. Completed at 1 site in Spain. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-09.

Sponsored by Instituto Sexológico Murciano · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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).

02

Conditions studied

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

Keywords

  • premature ejaculation
  • cognitive-behavior
  • treatment
  • device
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts 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

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).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    device

    Device: Exercise Programme +device+ lubricant

  • Active comparator
    behavioral

    Behavioral: Exercise Programme + lubricant

  • No intervention
    waiting list

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 7 weeks

Secondary outcomes

  1. 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.

    Time frame: 7 weeks

Other outcomes

  1. Golombok Rust Inventory of Sexual Satisfaction (GRISS)

    Scale ejaculatory function

    Time frame: 7 weeks

06

Study locations

1 site
  • Jesús Rodríguez
    Murcia, 30007, Spain
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03304808
Lead sponsor
Instituto Sexológico Murciano
Collaborators
Universidad Miguel Hernandez de Elche
Responsible party
Sponsor
First posted
Oct 9, 2017
Start date
Oct 1, 2017
Primary completion
Oct 30, 2017
Completion
Dec 1, 2017
Last update
Jul 9, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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