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A New Treatment for Premature Ejaculation?

Primary Purpose

Premature Ejaculation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FLIP HOLE
Sponsored by
Instituto Sexológico Murciano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring Premature ejaculation treatment, Sexual dysfunction, Intravaginal Ejaculatory Latency time, Masturbation aid, Ejaculatory disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    FLIP HOLE

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Golombok Rust Sexual Inventory of Satisfaction
    subjects completing the questionnaire at the beginning of the investigation and when finalized using the Flip-Hole Masturbator device

    Full Information

    First Posted
    November 14, 2014
    Last Updated
    November 20, 2014
    Sponsor
    Instituto Sexológico Murciano
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02297152
    Brief Title
    A New Treatment for Premature Ejaculation?
    Official Title
    A New Treatment for Premature Ejaculation? Case Series for a Desensitizing Masturbation Aid
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Sexológico Murciano

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ejaculation
    Keywords
    Premature ejaculation treatment, Sexual dysfunction, Intravaginal Ejaculatory Latency time, Masturbation aid, Ejaculatory disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FLIP HOLE
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    FLIP HOLE
    Intervention Description
    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 Measure Information:
    Title
    the Intravaginal Ejaculatory Latency Time
    Description
    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.
    Time Frame
    05/2014-09/2014 (during a minimum of five minutes without never overcoming half daily hour)
    Secondary Outcome Measure Information:
    Title
    Golombok Rust Sexual Inventory of Satisfaction
    Description
    subjects completing the questionnaire at the beginning of the investigation and when finalized using the Flip-Hole Masturbator device
    Time Frame
    05/2014-09/2014 (up to 4 months)

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

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    A New Treatment for Premature Ejaculation?

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