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

I

Instituto Sexológico Murciano

Status

Completed

Conditions

Masturbation Aid Device
Premature Ejaculation
Cognitive-Behavior Treatment

Treatments

Behavioral: Exercise Programme + lubricant
Device: Exercise Programme +device+ lubricant

Study type

Interventional

Funder types

Other

Identifiers

NCT03304808
ISMSEXOLOGIA

Details and patient eligibility

About

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).

Enrollment

35 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 3 patient groups

device
Experimental group
Treatment:
Device: Exercise Programme +device+ lubricant
behavioral
Active Comparator group
Treatment:
Behavioral: Exercise Programme + lubricant
waiting list
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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