<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/NCT02984592</url>
  </required_header>
  <id_info>
    <org_study_id>5006</org_study_id>
    <nct_id>NCT02984592</nct_id>
  </id_info>
  <brief_title>Effect of Exercise on Premature Ejaculation</brief_title>
  <official_title>Regular Physical Activity Improves Ejaculation Time and Patient-reported Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such&#xD;
      as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and&#xD;
      their partners. The current study was aimed to evaluate the relationship between ejaculation&#xD;
      and physical activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Premature ejaculation (PE) is the most frequent sexual dysfunction in males, and its&#xD;
      prevalence has been reported as 21-33%. Currently, there are no universal criteria for the&#xD;
      diagnosis, or treatment strategies or approaches for PE. Lack of observational studies&#xD;
      directed to PE makes comprehension of this sexual dysfunction difficult. The common point for&#xD;
      definition of PE is a short duration between penetration and ejaculation, little or no&#xD;
      control on voluntary control of ejaculation, and annoying character and negative effect of&#xD;
      this condition on the individual. There are various treatment methods since ejaculation&#xD;
      physiology and neuroanatomy is not yet clearly demonstrated. According to neurobiological&#xD;
      hypothesis of Waldinger, a dysfunction in the serotonin pathway of the central system such as&#xD;
      serotonin-2C hyposensitivity and/or serotonin-1A receptor hypersensitivity is a possible&#xD;
      cause of lifelong PE. These experimental animal models showed that serotonergic activity at&#xD;
      hypothalamic level inhibited ejaculation reflex. Based on this physiological effect,&#xD;
      selective serotonin reuptake inhibitors (SSRI), and serotonin agonists increase intravaginal&#xD;
      ejaculation latency time (IELT). A number of studies showed that exercise increased the&#xD;
      functional effect of serotonin in the human brain.&#xD;
&#xD;
      The effects of physical activity level on human health have attracted interest worldwide.&#xD;
      Lack of physical activity forms the basis of various health problems, however regular&#xD;
      physical act contributes prevention and treatment of a number of disorders.&#xD;
&#xD;
      In current study, investigators will compare the ejaculation control, IELT, and prevalence of&#xD;
      PE between sportsmen that have regular physical activity, and the individuals with a&#xD;
      sedentary lifestyle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">January 31, 2017</completion_date>
  <primary_completion_date type="Actual">January 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>intravaginal ejaculatory latency time</measure>
    <time_frame>1 month</time_frame>
    <description>IELT value (second) according to the duration determined by the sexual partner with stopwatch method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Premature ejaculation diagnostic tool score</measure>
    <time_frame>1 month</time_frame>
    <description>Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, score 8 indicates no premature ejaculation, scores 9 and 10 indicate possible premature ejaculation, and scores equal or higher than 11 indicates premature ejaculation.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Premature Ejaculation</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>The participants in group 1 will state that they participate regular exercise programs in the previous 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>The participants in group 2 will state that they do not perform any regular exercise in previous 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>physical exercise</intervention_name>
    <description>regular exercise programs in the previous 6 months.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participants are 18-45 year-old, and have regular sexual activity for at least 6&#xD;
        months. A comparison was made by metabolic equivalents (MET), premature ejaculation&#xD;
        diagnostic tool (PEDT) and intravaginal ejaculatory latency time (IELT).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45-year-old&#xD;
&#xD;
          -  sexually active&#xD;
&#xD;
          -  heterosexual,without erectile dysfunction&#xD;
&#xD;
          -  sexual partner for at least six months, and sexual intercourse at least twice a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic systemic disorders (such as diabetes or hypertension)&#xD;
&#xD;
          -  use of narcotic/hypnotic drugs or stimulants&#xD;
&#xD;
          -  anabolic steroids&#xD;
&#xD;
          -  selective serotonin receptors inhibitors&#xD;
&#xD;
          -  previous diagnosis and treatment for PE&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ankara Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Pastore AL, Palleschi G, Leto A, Pacini L, Iori F, Leonardo C, Carbone A. A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine for treatment of lifelong premature ejaculation. Int J Androl. 2012 Aug;35(4):528-33. doi: 10.1111/j.1365-2605.2011.01243.x. Epub 2012 Feb 9.</citation>
    <PMID>22320846</PMID>
  </results_reference>
  <results_reference>
    <citation>Pastore AL, Palleschi G, Fuschi A, Maggioni C, Rago R, Zucchi A, Costantini E, Carbone A. Pelvic floor muscle rehabilitation for patients with lifelong premature ejaculation: a novel therapeutic approach. Ther Adv Urol. 2014 Jun;6(3):83-8. doi: 10.1177/1756287214523329.</citation>
    <PMID>24883105</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Muhammet Fatih Kilinc</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>premature ejaculation</keyword>
  <keyword>intravaginal ejaculatory latency time</keyword>
  <keyword>premature ejaculation diagnostic tools</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>Yes</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/NCT02984592
org study id: 5006
nct id: NCT02984592
lead sponsor: 
has dmc: Yes
Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such
      as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and
      their partners. The current study was aimed to evaluate the relationship between ejaculation
      and physical activity.
Premature ejaculation (PE) is the most frequent sexual dysfunction in males, and its
      prevalence has been reported as 21-33%. Currently, there are no universal criteria for the
      diagnosis, or treatment strategies or approaches for PE. Lack of observational studies
      directed to PE makes comprehension of this sexual dysfunction difficult. The common point for
      definition of PE is a short duration between penetration and ejaculation, little or no
      control on voluntary control of ejaculation, and annoying character and negative effect of
      this condition on the individual. There are various treatment methods since ejaculation
      physiology and neuroanatomy is not yet clearly demonstrated. According to neurobiological
      hypothesis of Waldinger, a dysfunction in the serotonin pathway of the central system such as
      serotonin-2C hyposensitivity and/or serotonin-1A receptor hypersensitivity is a possible
      cause of lifelong PE. These experimental animal models showed that serotonergic activity at
      hypothalamic level inhibited ejaculation reflex. Based on this physiological effect,
      selective serotonin reuptake inhibitors (SSRI), and serotonin agonists increase intravaginal
      ejaculation latency time (IELT). A number of studies showed that exercise increased the
      functional effect of serotonin in the human brain.

      The effects of physical activity level on human health have attracted interest worldwide.
      Lack of physical activity forms the basis of various health problems, however regular
      physical act contributes prevention and treatment of a number of disorders.

      In current study, investigators will compare the ejaculation control, IELT, and prevalence of
      PE between sportsmen that have regular physical activity, and the individuals with a
      sedentary lifestyle.
observational model: Cohort
time perspective: Cross-Sectional
measure: intravaginal ejaculatory latency time
time frame: 1 month
description: IELT value (second) according to the duration determined by the sexual partner with stopwatch method
measure: Premature ejaculation diagnostic tool score
time frame: 1 month
description: Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, score 8 indicates no premature ejaculation, scores 9 and 10 indicate possible premature ejaculation, and scores equal or higher than 11 indicates premature ejaculation.
arm group label: Group 1
description: The participants in group 1 will state that they participate regular exercise programs in the previous 6 months
arm group label: Group 2
description: The participants in group 2 will state that they do not perform any regular exercise in previous 6 months.
intervention type: Behavioral
intervention name: physical exercise
description: regular exercise programs in the previous 6 months.
arm group label: Group 1
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
citation: Pastore AL, Palleschi G, Leto A, Pacini L, Iori F, Leonardo C, Carbone A. A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine for treatment of lifelong premature ejaculation. Int J Androl. 2012 Aug;35(4):528-33. doi: 10.1111/j.1365-2605.2011.01243.x. Epub 2012 Feb 9.
PMID: 22320846
citation: Pastore AL, Palleschi G, Fuschi A, Maggioni C, Rago R, Zucchi A, Costantini E, Carbone A. Pelvic floor muscle rehabilitation for patients with lifelong premature ejaculation: a novel therapeutic approach. Ther Adv Urol. 2014 Jun;6(3):83-8. doi: 10.1177/1756287214523329.
PMID: 24883105
responsible party type: Principal Investigator
investigator affiliation: Ankara Training and Research Hospital
investigator full name: Muhammet Fatih Kilinc
investigator title: M.D.
mesh term: Premature Birth
mesh term: Premature Ejaculation
sharing ipd: Yes