An interventional study of FLIP HOLE in Premature Ejaculation, sponsored by Instituto Sexológico Murciano. Completed. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-21.
Sponsored by Instituto Sexológico Murciano · Not applicable, Interventional, and Treatment
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.
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.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 10 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Instituto Sexológico Murciano is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: 05/2014-09/2014 (during a minimum of five minutes without never overcoming half daily hour)
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
Time frame: 05/2014-09/2014 (up to 4 months)
No study locations are listed for this record.
The record gives a start of May 2014, a primary completion of Sep 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Instituto Sexológico Murciano