A New Treatment for Premature Ejaculation?
Primary Purpose
Premature Ejaculation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FLIP HOLE
Sponsored by
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
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
NCT ID
NCT02297152
First Posted
November 14, 2014
Last Updated
November 20, 2014
Sponsor
Instituto Sexológico Murciano
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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