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Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0

Primary Purpose

Premature Ejaculation, Cognitive-Behavior Treatment, Masturbation Aid Device

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise Programme +device+ lubricant
Exercise Programme + lubricant
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, cognitive-behavior, treatment, device

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must be heterosexual males
  • To be in a stable monogamous, sexual relationship with a female partner for at least 6 months,
  • Must score = 11 in the Premature Ejaculation Diagnostic Tool (PEDT).
  • Must have a self-estimated average intravaginal ejaculatory latency time (IELT) of <2 min. -Must be in good general health with no clinically significant abnormalities as determined by medical history and clinical lab results.

Exclusion Criteria:

  • To suffer an alteration or mental disorder according to the criteria of the DSM-IV.
  • History of alcohol abuse and dependence.
  • Do not to consume medication, drugs of recreative use or alcohol (except for caffeine or nicotine/tobacco).

Sites / Locations

  • Jesús Rodríguez

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

device

behavioral

waiting list

Arm Description

Outcomes

Primary Outcome Measures

IELT FOLD INCREASE
fold changes are defined directly in terms of ratios.If the initial value is A and the final value B, the fold change is defined as B/A

Secondary Outcome Measures

Premature Ejaculation Profile (PEP)
proportion of patients who achieved criteria for clinical benefit, defined as achieving a two-category or greater increase in the change in control over ejaculation and level of satisfaction with intercourse, and a one-category or greater increase in the change in ejaculation-related distress and degree of interpersonal difficulty.

Full Information

First Posted
March 30, 2017
Last Updated
July 6, 2018
Sponsor
Instituto Sexológico Murciano
Collaborators
Universidad Miguel Hernandez de Elche
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1. Study Identification

Unique Protocol Identification Number
NCT03304808
Brief Title
Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0
Official Title
A Randomized, Controlled Study of the Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Sexológico Murciano
Collaborators
Universidad Miguel Hernandez de Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study included 57 patients ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ≥11. Subjects were randomized to an experimental group that used the device with exercise programme (n=18) a first control group that only used the exercise programme (n=17) and a wait-list control group (n=22). As a main outcome measure used stopwatch-measured average IELT, Premature Ejaculation Profile (PEP), and the Golombok-Rust Inventory of Sexual Satisfaction (GRISS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation, Cognitive-Behavior Treatment, Masturbation Aid Device
Keywords
premature ejaculation, cognitive-behavior, treatment, device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
device
Arm Type
Experimental
Arm Title
behavioral
Arm Type
Active Comparator
Arm Title
waiting list
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Exercise Programme +device+ lubricant
Intervention Description
A first line treatment for the PE of a new 7 weeks exercise programme to control male orgasm using a masturbation aid device in a variation of the classical stop-start technique first introduced by Semans in 1956. Four exercise: Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area . Star and Stop to identify the tension and try to reduce this tension, on the pelvic floor muscles pay special attention to the anal sphincter. Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating
Intervention Type
Behavioral
Intervention Name(s)
Exercise Programme + lubricant
Intervention Description
A first line treatment for the PE of a new 7 weeks exercise programme to control male orgasm using a masturbation aid device in a variation of the classical stop-start technique first introduced by Semans in 1956. Four exercise: Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area . Star and Stop to identify the tension and try to reduce this tension, on the pelvic floor muscles pay special attention to the anal sphincter. Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating
Primary Outcome Measure Information:
Title
IELT FOLD INCREASE
Description
fold changes are defined directly in terms of ratios.If the initial value is A and the final value B, the fold change is defined as B/A
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Premature Ejaculation Profile (PEP)
Description
proportion of patients who achieved criteria for clinical benefit, defined as achieving a two-category or greater increase in the change in control over ejaculation and level of satisfaction with intercourse, and a one-category or greater increase in the change in ejaculation-related distress and degree of interpersonal difficulty.
Time Frame
7 weeks
Other Pre-specified Outcome Measures:
Title
Golombok Rust Inventory of Sexual Satisfaction (GRISS)
Description
Scale ejaculatory function
Time Frame
7 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must be heterosexual males To be in a stable monogamous, sexual relationship with a female partner for at least 6 months, Must score = 11 in the Premature Ejaculation Diagnostic Tool (PEDT). Must have a self-estimated average intravaginal ejaculatory latency time (IELT) of <2 min. -Must be in good general health with no clinically significant abnormalities as determined by medical history and clinical lab results. Exclusion Criteria: To suffer an alteration or mental disorder according to the criteria of the DSM-IV. History of alcohol abuse and dependence. Do not to consume medication, drugs of recreative use or alcohol (except for caffeine or nicotine/tobacco).
Facility Information:
Facility Name
Jesús Rodríguez
City
Murcia
ZIP/Postal Code
30007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0

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