Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A New Treatment for Premature Ejaculation?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02297152
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Jesus Eugenio Rodríguez Martínez, 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.

Condition or disease Intervention/treatment Phase
Premature Ejaculation Device: FLIP HOLE Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A New Treatment for Premature Ejaculation? Case Series for a Desensitizing Masturbation Aid
Study Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
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
Device: FLIP HOLE
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.




Primary Outcome Measures :
  1. the Intravaginal Ejaculatory Latency Time [ Time Frame: 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 :
  1. Golombok Rust Sexual Inventory of Satisfaction [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Layout table for additonal information
Responsible Party: Jesus Eugenio Rodríguez Martínez, Sexólogo, Instituto Sexológico Murciano
ClinicalTrials.gov Identifier: NCT02297152     History of Changes
Other Study ID Numbers: InstitutoSM
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014
Keywords provided by Jesus Eugenio Rodríguez Martínez, Instituto Sexológico Murciano:
Premature ejaculation treatment
Sexual dysfunction
Intravaginal Ejaculatory Latency time
Masturbation aid
Ejaculatory disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders