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
1 other identifier
interventional
35
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedFirst Posted
Study publicly available on registry
October 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 9, 2018
July 1, 2018
29 days
March 30, 2017
July 6, 2018
Conditions
Keywords
Outcome Measures
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
7 weeks
Secondary Outcomes (1)
Premature Ejaculation Profile (PEP)
7 weeks
Other Outcomes (1)
Golombok Rust Inventory of Sexual Satisfaction (GRISS)
7 weeks
Study Arms (3)
device
EXPERIMENTALbehavioral
ACTIVE COMPARATORwaiting list
NO INTERVENTIONInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jesús Rodríguez
Murcia, 30007, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2017
First Posted
October 9, 2017
Study Start
October 1, 2017
Primary Completion
October 30, 2017
Study Completion
December 1, 2017
Last Updated
July 9, 2018
Record last verified: 2018-07