xml: <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/NCT05964608</url>
    </required_header>
    <id_info>
      <org_study_id>GAUN-EBE-EK-01</org_study_id>
      <nct_id>NCT05964608</nct_id>
    </id_info>
    <brief_title>The Effect of Behavioral Therapy Given to Men and Their Partners'</brief_title>
    <official_title>The Effect of Behavioral Therapy Given to Men With Premature Ejaculation on Symptoms and Their Partners' Sexual Functioning and Sexual Quality of Life</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Gaziantep</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Gaziantep</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>
        Premature ejaculation involves not only sexual problems but also relationship and&#xD;
        communication difficulties, and behavioral approaches to the treatment of premature&#xD;
        ejaculation are promising.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction and hypothesis: Premature ejaculation potentially affects not only men but also&#xD;
        their partners negatively. The null hypothesis for this study is Behavioral therapy given to&#xD;
        men with premature ejaculation has no effect on the symptoms and their partners' sexual&#xD;
        functions and quality of sexual life.&#xD;
  &#xD;
        Methods: A quasi-experimental study. The current study was conducted in 84 men and their&#xD;
        partners. The &quot;Personal Information Form&quot;, &quot;Premature Ejaculation Diagnostic Tool (PEDT)&quot;,&#xD;
        &quot;Female Sexual Function Index (FSFI)&quot;, and &quot;Sexual Quality of Life-Female (SQOL-F)&quot; were used&#xD;
        to collect data. Behavioral therapy, consisting of a total of 6 sessions of 45 minutes, was&#xD;
        applied once every two weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 30, 2021</start_date>
    <completion_date type="Actual">March 15, 2022</completion_date>
    <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Premature Ejaculation Diagnostic Tool (PEDT)</measure>
      <time_frame>six weeks</time_frame>
      <description>it was developed by Symonds et al. (2007) to better define premature ejaculation for use in clinical studies, this is a 5-point Likert-type scale consisting of 5 items. The scale was adapted to Turkish by Serefoglu et al. (2009). The highest score that can be obtained from the scale is 20.0 and the lowest score is 0.0. Scores higher than 11 are defined as &quot;PE&quot;, scores of 9-10 are defined as &quot;possible PE&quot;, and scores of eight or less are defined as &quot;no PE&quot;.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Female Sexual Function Index (FSFI)</measure>
      <time_frame>six weeks</time_frame>
      <description>Developed by Rosen et al. in 2000, the Female Sexual Function Index (FSFI) is a multidimensional scale consisting of six sections and 19 items evaluating female sexual function. The scale was adapted to Turkish by Aygin and Eti Aslan (2005). The scale contains six sub-dimensions: desire, arousal, lubrication (wetting), orgasm, satisfaction, and pain. The highest score that can be obtained from the scale is 36.0 and the lowest is 2.0. As the score obtained from the scale increases, sexual function improves. The simple mathematical algorithm calculation is organized to determine the scoring of the subscales and the entire scale. Factor loads were determined as 0.6 for desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sexual Quality of Life-Female (SQOL-F)</measure>
      <time_frame>six weeks</time_frame>
      <description>It was developed by Symonds et al. in 2005, the Sexual Quality of Life-Female (SQOL-F) is a six-point Likert-type questionnaire consisting of 18 items to evaluate women's sexual quality of life. Tugut and Golbasi (2010) adapted the questionnaire to Turkish in 2010. Each item addresses sexual life over the preceding four weeks. The questionnaire uses a 1-6 point system (1-totally agree, 2-strongly agree, 3-somewhat disagree, 5-strongly disagree, 6-totally disagree), and the range of points that can be obtained is between 18 and 108. As the score obtained from the questionnaire increases, the quality of sexual life increases.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">84</enrollment>
    <condition>Premature Ejaculation</condition>
    <condition>Sexual Function Disturbances</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pre-tests were applied to the men (Personal Information Form and PEDT) and their spouses (Personal Information Form, FSFI, and SQOL-F) just before the behavioral treatment was applied to the men in the treatment group. In the first interview with the men, the researchers delivered information about behavioral therapy and set therapy days and hours. Structured interviews, consisting of a total of 6 sessions, were held once every two weeks for men with premature ejaculation problems. Behavioral therapy took place once every two weeks for a total of six 45-minute sessions. The &quot;stop-start technique&quot; was the therapy used. Behavioral therapy interviews were conducted at the urology outpatient clinic of the hospital. Post-tests were administered to men with premature ejaculation (PEDT) and their spouses (FSFI and SQOL-F) immediately after the 6th session was completed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioral Therapy</intervention_name>
      <description>Structured interviews, consisting of a total of 6 sessions, were held once every two weeks for men with premature ejaculation problems. Behavioral therapy took place once every two weeks for a total of six 45-minute sessions. The &quot;stop-start technique&quot; was the therapy used. Behavioral therapy interviews were conducted at the urology outpatient clinic of the hospital. Post-tests were administered to men with premature ejaculation (PEDT) and their spouses (FSFI and SQOL-F) immediately after the 6th session was completed.</description>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Willingness to participate&#xD;
  &#xD;
            -  Having no communication barriers&#xD;
  &#xD;
            -  Literacy&#xD;
  &#xD;
            -  Age 18-45 years&#xD;
  &#xD;
            -  Having no diagnosis of sexual dysfunctions&#xD;
  &#xD;
            -  Having no medical illnesses (psychiatric diseases, pelvic anatomical disorder,&#xD;
               post-menopause, etc.) that might affect the sexual function&#xD;
  &#xD;
            -  Having a spouse diagnosed with premature ejaculation according to DSM-5 criteria&#xD;
  &#xD;
            -  Having a spouse without any prior behavioral therapy for premature ejaculation&#xD;
  &#xD;
            -  Being a man diagnosed with lifelong premature ejaculation according to the ISSM&#xD;
               criteria.&#xD;
  &#xD;
            -  Being married&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -Men and their partners who did not meet all inclusion criteria were excluded from the&#xD;
          present study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kazım Doğan, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istinye University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>ECE</name>
        <address>
          <city>Gaziantep</city>
          <zip>0027</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Gaziantep</investigator_affiliation>
      <investigator_full_name>Ece Kaplan</investigator_full_name>
      <investigator_title>Asst. Prof.</investigator_title>
    </responsible_party>
    <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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964608
  org study id: GAUN-EBE-EK-01
  nct id: NCT05964608
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Premature ejaculation involves not only sexual problems but also relationship and
        communication difficulties, and behavioral approaches to the treatment of premature
        ejaculation are promising.
  Introduction and hypothesis: Premature ejaculation potentially affects not only men but also
        their partners negatively. The null hypothesis for this study is Behavioral therapy given to
        men with premature ejaculation has no effect on the symptoms and their partners' sexual
        functions and quality of sexual life.
  
        Methods: A quasi-experimental study. The current study was conducted in 84 men and their
        partners. The "Personal Information Form", "Premature Ejaculation Diagnostic Tool (PEDT)",
        "Female Sexual Function Index (FSFI)", and "Sexual Quality of Life-Female (SQOL-F)" were used
        to collect data. Behavioral therapy, consisting of a total of 6 sessions of 45 minutes, was
        applied once every two weeks.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Premature Ejaculation Diagnostic Tool (PEDT)
  time frame: six weeks
  description: it was developed by Symonds et al. (2007) to better define premature ejaculation for use in clinical studies, this is a 5-point Likert-type scale consisting of 5 items. The scale was adapted to Turkish by Serefoglu et al. (2009). The highest score that can be obtained from the scale is 20.0 and the lowest score is 0.0. Scores higher than 11 are defined as "PE", scores of 9-10 are defined as "possible PE", and scores of eight or less are defined as "no PE".
  measure: Female Sexual Function Index (FSFI)
  time frame: six weeks
  description: Developed by Rosen et al. in 2000, the Female Sexual Function Index (FSFI) is a multidimensional scale consisting of six sections and 19 items evaluating female sexual function. The scale was adapted to Turkish by Aygin and Eti Aslan (2005). The scale contains six sub-dimensions: desire, arousal, lubrication (wetting), orgasm, satisfaction, and pain. The highest score that can be obtained from the scale is 36.0 and the lowest is 2.0. As the score obtained from the scale increases, sexual function improves. The simple mathematical algorithm calculation is organized to determine the scoring of the subscales and the entire scale. Factor loads were determined as 0.6 for desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain.
  measure: Sexual Quality of Life-Female (SQOL-F)
  time frame: six weeks
  description: It was developed by Symonds et al. in 2005, the Sexual Quality of Life-Female (SQOL-F) is a six-point Likert-type questionnaire consisting of 18 items to evaluate women's sexual quality of life. Tugut and Golbasi (2010) adapted the questionnaire to Turkish in 2010. Each item addresses sexual life over the preceding four weeks. The questionnaire uses a 1-6 point system (1-totally agree, 2-strongly agree, 3-somewhat disagree, 5-strongly disagree, 6-totally disagree), and the range of points that can be obtained is between 18 and 108. As the score obtained from the questionnaire increases, the quality of sexual life increases.
  arm group label: Treatment group
  arm group type: Experimental
  description: Pre-tests were applied to the men (Personal Information Form and PEDT) and their spouses (Personal Information Form, FSFI, and SQOL-F) just before the behavioral treatment was applied to the men in the treatment group. In the first interview with the men, the researchers delivered information about behavioral therapy and set therapy days and hours. Structured interviews, consisting of a total of 6 sessions, were held once every two weeks for men with premature ejaculation problems. Behavioral therapy took place once every two weeks for a total of six 45-minute sessions. The "stop-start technique" was the therapy used. Behavioral therapy interviews were conducted at the urology outpatient clinic of the hospital. Post-tests were administered to men with premature ejaculation (PEDT) and their spouses (FSFI and SQOL-F) immediately after the 6th session was completed.
  intervention type: Behavioral
  intervention name: Behavioral Therapy
  description: Structured interviews, consisting of a total of 6 sessions, were held once every two weeks for men with premature ejaculation problems. Behavioral therapy took place once every two weeks for a total of six 45-minute sessions. The "stop-start technique" was the therapy used. Behavioral therapy interviews were conducted at the urology outpatient clinic of the hospital. Post-tests were administered to men with premature ejaculation (PEDT) and their spouses (FSFI and SQOL-F) immediately after the 6th session was completed.
  arm group label: Treatment group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Kazım Doğan, Dr.
  role: Principal Investigator
  affiliation: Istinye University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: University of Gaziantep
  investigator full name: Ece Kaplan
  investigator title: Asst. Prof.
  mesh term: Premature Birth
  mesh term: Premature Ejaculation
  sharing ipd: No