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

NCT ID: NCT03304808

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2017-12-01

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).

Conditions

Premature Ejaculation; Cognitive-Behavior Treatment; Masturbation Aid Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

device

Group Type: EXPERIMENTAL

Exercise Programme +device+ lubricant

Intervention Type: DEVICE

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

behavioral

Group Type: ACTIVE_COMPARATOR

Exercise Programme + lubricant

Intervention Type: BEHAVIORAL

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

waiting list

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: collaborator

Instituto Sexológico Murciano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jesús Rodríguez

Murcia, , Spain

Countries

Spain

Other Identifiers

ISMSEXOLOGIA

Identifier Type: -

Identifier Source: org_study_id