A New Treatment for Premature Ejaculation?

NCT02297152 | Completed

• 1 other identifier: InstitutoSM
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of study is to determine if they can produce increases in the IELT using a masturbator in subjects with premature ejaculation, producing improvements in the quality and satisfaction of the sexuality of the patient.

Conditions

Premature Ejaculation

Keywords

Premature ejaculation treatment; Sexual dysfunction; Intravaginal Ejaculatory Latency time; Masturbation aid; Ejaculatory disorders

Outcome Measures

Primary Outcomes (1)

• the Intravaginal Ejaculatory Latency Time

  During the first two weeks of research the subjects had to register the ejaculatory latency times during the manual masturbation and the intercourse being from the third week when they would use the device FLIP HOLE in the manual masturbation either alone or in company of the couple but never during the intercourse. The subjects had to use the masturbator aid at least five times per week for six weeks, during a minimum of five minutes without never overcoming half daily hour and during intercourse.

  05/2014-09/2014 (during a minimum of five minutes without never overcoming half daily hour)

Secondary Outcomes (1)

• Golombok Rust Sexual Inventory of Satisfaction

  05/2014-09/2014 (up to 4 months)

Study Arms (1)

FLIP HOLE

OTHER

The device Flip Hole is a masturbation aid made from Thermoplastic Elastomer (a silicone like substance) that the user inserts their penis in to for stimulation

Device: FLIP HOLE

Interventions

FLIP HOLE DEVICE

The subjects had to use the masturbator aid at least five times per week for six weeks, during a minimum of five minutes without never overcoming half daily hour and during intercourse. The device Flip Hole is a masturbation aid made from Thermoplastic Elastomer (a silicone like substance) that the user inserts their penis in to for stimulation.

FLIP HOLE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient meets ISSM definition of PE
• Patient is 18 - 65 years

You may not qualify if:

• Patient has significant cardiovascular or neurological pathology.
• Patient has diabetes mellitus
• Patient is currently misusing alcohol/drugs
• Patient meets MCMI-III criteria for personality disorders and clinical syndromes

Sponsors & Collaborators

• Instituto Sexológico Murciano: lead

MeSH Terms

Conditions

Premature Ejaculation; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sexólogo

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 21, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 21, 2014

Record last verified: 2014-11