A New Treatment for Premature Ejaculation?

Not Applicable

Completed

• Conditions: Premature Ejaculation
• Interventions: Device: FLIP HOLE

• Registration Number: NCT02297152
• Lead Sponsor: Instituto Sexológico Murciano

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.

Detailed Description

From the assignment of the devices masturbation aid Flip Hole by the Japanese company TENGA® it was possible to begin to develop the study. To shape the patients sample was used to the active search of participants who met with the criteria of incorporation established for the participation in the study, from the publication of the study in different social media (Facebook, Twitter ...) and the review of the database of the Instituto Sexológico Murciano patients' (ISM) who had represented previously with problems of premature ejaculation.

First interview with the participants was carried out where it informed them about the collaborative character in the study, together with the informed assent. To determine the suitability of the sample one administered ISM's Autobiographical questionnaire, the clinical Multiaxial Inventory of Millon-III (MCMI-III), and the Questionnaire of sexual satisfaction GRISS (Golombok Rust Sexual Inventory of Satisfaction), beside gathering a medical report of every patient to reject pathologies that they could interfere with the study.

Once established the number of participants, 15 males of ages included between 18 and 65 years, there was carried out a follow-up individualized for eight weeks from records of the IELT. 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. 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.

The patients had to come weekly to ISM to deliver the weekly records and to be able to take a follow-up of the subjects along the process. Once finished eight weeks of the study one turned them to administer the questionnaire GRISS to evaluate if changes are produced in the sexual satisfaction of the participants.

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2014-11
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-20
• Last Update Submitted: 2014-11-20
• Study First Posted: 2014-11-21
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLIP HOLE	FLIP HOLE	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

Primary Outcome Measures

Name	Time	Method
the Intravaginal Ejaculatory Latency Time	05/2014-09/2014 (during a minimum of five minutes without never overcoming half daily hour)	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.

Secondary Outcome Measures

Name	Time	Method
Golombok Rust Sexual Inventory of Satisfaction	05/2014-09/2014 (up to 4 months)	subjects completing the questionnaire at the beginning of the investigation and when finalized using the Flip-Hole Masturbator device