ClinicalTrials.gg
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

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Keywords

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

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's enrollment of 35 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

Instituto Sexológico Murciano is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 .
  • History of alcohol abuse and dependence.
  • Do not to consume medication, drugs of recreative use or alcohol (except for caffeine or nicotine/tobacco).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

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

06

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

07

Study locations

1 site
  • Jesús Rodríguez
    Murcia, 30007, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Oct 2017, 0 months.

Of 25 interventional studies with no phase under Premature Ejaculation, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2017
First posted
Oct 9, 2017
StartActual
Oct 1, 2017
Primary completionActual
Oct 30, 2017
CompletionActual
Dec 1, 2017
Last update
Jul 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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