<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03304808</url>
  </required_header>
  <id_info>
    <org_study_id>ISMSEXOLOGIA</org_study_id>
    <nct_id>NCT03304808</nct_id>
  </id_info>
  <brief_title>Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0</brief_title>
  <official_title>A Randomized, Controlled Study of the Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Sexológico Murciano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Miguel Hernandez de Elche</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Sexológico Murciano</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study included 57 patients ≥18 years who met diagnostic criteria for PE including&#xD;
      intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation&#xD;
      Diagnostic Tool (PEDT) score ≥11.&#xD;
&#xD;
      Subjects were randomized to an experimental group that used the device with exercise&#xD;
      programme (n=18) a first control group that only used the exercise programme (n=17) and a&#xD;
      wait-list control group (n=22).&#xD;
&#xD;
      As a main outcome measure used stopwatch-measured average IELT, Premature Ejaculation Profile&#xD;
      (PEP), and the Golombok-Rust Inventory of Sexual Satisfaction (GRISS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IELT FOLD INCREASE</measure>
    <time_frame>7 weeks</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Premature Ejaculation Profile (PEP)</measure>
    <time_frame>7 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Golombok Rust Inventory of Sexual Satisfaction (GRISS)</measure>
    <time_frame>7 weeks</time_frame>
    <description>Scale ejaculatory function</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Premature Ejaculation</condition>
  <condition>Cognitive-Behavior Treatment</condition>
  <condition>Masturbation Aid Device</condition>
  <arm_group>
    <arm_group_label>device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>behavioral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>waiting list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exercise Programme +device+ lubricant</intervention_name>
    <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.&#xD;
Four exercise:&#xD;
Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area .&#xD;
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.&#xD;
Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating&#xD;
Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating</description>
    <arm_group_label>device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Programme + lubricant</intervention_name>
    <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.&#xD;
Four exercise:&#xD;
Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area .&#xD;
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.&#xD;
Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating&#xD;
Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating</description>
    <arm_group_label>behavioral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be heterosexual males&#xD;
&#xD;
          -  To be in a stable monogamous, sexual relationship with a female partner for at least 6&#xD;
             months,&#xD;
&#xD;
          -  Must score = 11 in the Premature Ejaculation Diagnostic Tool (PEDT).&#xD;
&#xD;
          -  Must have a self-estimated average intravaginal ejaculatory latency time (IELT) of &lt;2&#xD;
             min. -Must be in good general health with no clinically significant abnormalities as&#xD;
             determined by medical history and clinical lab results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To suffer an alteration or mental disorder according to the criteria of the DSM-IV.&#xD;
&#xD;
          -  History of alcohol abuse and dependence.&#xD;
&#xD;
          -  Do not to consume medication, drugs of recreative use or alcohol (except for caffeine&#xD;
             or nicotine/tobacco).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jesús Rodríguez</name>
      <address>
        <city>Murcia</city>
        <zip>30007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>March 30, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>July 6, 2018</last_update_submitted>
  <last_update_submitted_qc>July 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>premature ejaculation</keyword>
  <keyword>cognitive-behavior</keyword>
  <keyword>treatment</keyword>
  <keyword>device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Premature Ejaculation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03304808
org study id: ISMSEXOLOGIA
nct id: NCT03304808
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: IELT FOLD INCREASE
time frame: 7 weeks
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
measure: Premature Ejaculation Profile (PEP)
time frame: 7 weeks
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.
measure: Golombok Rust Inventory of Sexual Satisfaction (GRISS)
time frame: 7 weeks
description: Scale ejaculatory function
arm group label: device
arm group type: Experimental
arm group label: behavioral
arm group type: Active Comparator
arm group label: waiting list
arm group type: No Intervention
intervention type: Device
intervention name: Exercise Programme +device+ lubricant
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
arm group label: device
intervention type: Behavioral
intervention name: Exercise Programme + lubricant
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
arm group label: behavioral
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Premature Ejaculation
sharing ipd: Undecided