<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/NCT03033082</url>
  </required_header>
  <id_info>
    <org_study_id>2014</org_study_id>
    <nct_id>NCT03033082</nct_id>
  </id_info>
  <brief_title>Evaluation of Marital and Sexual Satisfaction of Wives to Erectile Dysfunction Males</brief_title>
  <official_title>Evaluation of Marital and Sexual Satisfaction of Wives to Erectile Dysfunction Males Using Intra Corporeal Injection (Ici). In Correlation to Personality Profile</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adam International Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adam International Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Erectile Dysfunction (ED), previously known as sexual impotence, is defined as the persistent&#xD;
      inability to obtain and/or maintain a penile erection that is hard enough for satisfactory&#xD;
      sexual intercourse. The number of reported patients with ED is increasing and it is becoming&#xD;
      a real medical problem.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Marital satisfaction is a global evaluation of the state of one's marriage or current&#xD;
      long-term romantic relationship. This global evaluation can be a reflection of a how happy&#xD;
      people are in their marriage in general or a composite of satisfaction with several specific&#xD;
      facets of the marital relationship. Sexual health can be described as enjoying and fulfilling&#xD;
      sexual desires without harming, physical or psychological, oneself or others. Sexual&#xD;
      functioning is an important part of a patient's health and well-being. Patients often seek&#xD;
      for treatment late due to embarrassment and commonly with an alternative problem. Sexual and&#xD;
      erectile functions are considered important components of men's overall health. The&#xD;
      psychosocial impact of ED can lead to depression, loss of self-esteem, and relationship and&#xD;
      marital difficulties. Personality is defined as the &quot;distinctive and characteristic patterns&#xD;
      of thought, emotion and behavior that define an individual's personal style and influence his&#xD;
      or her interaction with the environment&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">June 30, 2014</completion_date>
  <primary_completion_date type="Actual">June 1, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Marital and sexual satisfaction.</measure>
    <time_frame>Six months.</time_frame>
    <description>Questionnaire sheets.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Erectile dysfunction patients</arm_group_label>
    <description>Questionnaire sheets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal males</arm_group_label>
    <description>Questionnaire sheets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire sheets</intervention_name>
    <description>A- Marital satisfaction Index (MSI). Interview (Modified Arabic translation)&#xD;
B- Sexual Satisfaction Scale:(SSS). The Arabic version of the sexual satisfaction scale was used.&#xD;
C- International Index of Erectile Function Questionnaire (IIEF-5): For male subjects.&#xD;
D- The Eysenck Personality Questionnaire (EPQ):&#xD;
The Arabic version of the EPQ was used.</description>
    <arm_group_label>Erectile dysfunction patients</arm_group_label>
    <arm_group_label>Normal males</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Males complaining of erectile dysfunction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Married couples&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unmarried couples.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Adam International Hospital</investigator_affiliation>
    <investigator_full_name>Ahmad Raef Sadek</investigator_full_name>
    <investigator_title>Prinicipal Investigator Ahmad Raef</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Contact the authors</ipd_description>
  </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/NCT03033082
org study id: 2014
nct id: NCT03033082
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Erectile Dysfunction (ED), previously known as sexual impotence, is defined as the persistent
      inability to obtain and/or maintain a penile erection that is hard enough for satisfactory
      sexual intercourse. The number of reported patients with ED is increasing and it is becoming
      a real medical problem.
Marital satisfaction is a global evaluation of the state of one's marriage or current
      long-term romantic relationship. This global evaluation can be a reflection of a how happy
      people are in their marriage in general or a composite of satisfaction with several specific
      facets of the marital relationship. Sexual health can be described as enjoying and fulfilling
      sexual desires without harming, physical or psychological, oneself or others. Sexual
      functioning is an important part of a patient's health and well-being. Patients often seek
      for treatment late due to embarrassment and commonly with an alternative problem. Sexual and
      erectile functions are considered important components of men's overall health. The
      psychosocial impact of ED can lead to depression, loss of self-esteem, and relationship and
      marital difficulties. Personality is defined as the "distinctive and characteristic patterns
      of thought, emotion and behavior that define an individual's personal style and influence his
      or her interaction with the environment".
observational model: Case-Control
time perspective: Prospective
measure: Marital and sexual satisfaction.
time frame: Six months.
description: Questionnaire sheets.
arm group label: Erectile dysfunction patients
description: Questionnaire sheets.
arm group label: Normal males
description: Questionnaire sheets.
intervention type: Other
intervention name: Questionnaire sheets
description: A- Marital satisfaction Index (MSI). Interview (Modified Arabic translation)
B- Sexual Satisfaction Scale:(SSS). The Arabic version of the sexual satisfaction scale was used.
C- International Index of Erectile Function Questionnaire (IIEF-5): For male subjects.
D- The Eysenck Personality Questionnaire (EPQ):
The Arabic version of the EPQ was used.
arm group label: Erectile dysfunction patients
arm group label: Normal males
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Adam International Hospital
investigator full name: Ahmad Raef Sadek
investigator title: Prinicipal Investigator Ahmad Raef
mesh term: Erectile Dysfunction
sharing ipd: Yes
ipd description: Contact the authors