<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/NCT04411485</url>
  </required_header>
  <id_info>
    <org_study_id>2016-098</org_study_id>
    <nct_id>NCT04411485</nct_id>
  </id_info>
  <brief_title>Sexual Dysfunction in Partner of Patients With Ankylosing Spondylitis</brief_title>
  <official_title>Evaluation of Sexual Satisfaction and Sexual Dysfunction in Partner of Patients With Ankylosing Spondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antalya Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antalya Training and Research Hospital</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 adverse effects of rheumatologic diseases, especially Ankylosing Spondylitis (AS), on&#xD;
      sexual functions are known. The causes of sexual dysfunction in rheumatologic diseases are&#xD;
      due to factors such as pain, weakness, fatigue, stiffness, functional disability, anxiety,&#xD;
      depression, hormonal deficiency, drug use, decreased libido and poor body image. Depending on&#xD;
      these factors, sexual intercourse and frequency of sexual intercourse may decrease. Sexual&#xD;
      dysfunction may be seen in AS due to physical and emotional problems caused by the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are many studies in the literature that determine sexual satisfaction and sexual&#xD;
      dysfunction in individuals with AS and compare individuals with AS to healthy individuals .&#xD;
      In the light of these studies, the investigators thought that the sexual function of partner&#xD;
      of individuals with AS may also be affected negatively. In the literature, no previous study&#xD;
      examines the sexual function of partner of individuals with AS. Therefore, the aim was to&#xD;
      determine the sexual function of partner of individuals with AS and to compare with healthly&#xD;
      adults of the same sex.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 15, 2018</start_date>
  <completion_date type="Anticipated">July 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</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>Female Sexual Function Scale</measure>
    <time_frame>1 week</time_frame>
    <description>It is a Likert-type scale that evaluates sexual dysfunction in women consisting of 19 items. The validity and reliability study of FSFI was performed by Rosen et al. (8). The scale consists of six items: desire, arousal, lubrication, orgasm, sexual satisfaction and pain. Each title is scored between 0 or 1 to 6. The lowest score is two (2) and the highest score is thirty-six (36). A higher score means better function. Rosen et al. (2000) in their study of functional status; The FSFI score was classified as good if&gt; 30, moderate between 23-29, and poor if &lt;23 .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Erectile Function Form</measure>
    <time_frame>1 week</time_frame>
    <description>The questionnaire, which consists of 15 questions in total, determines the participants' erectile function, orgasmic function, sexual desire, sexual satisfaction and overall satisfaction and these 5 different sexual function areas are scored according to the answers received. It is a Likert type scale. As the score increases, it means that each area is good.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <condition>Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>Group of Ankylosing Spondylitis</arm_group_label>
    <description>Patient with ankylosing spondylitis diagnosed by a rheumatologist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group of control</arm_group_label>
    <description>Healthy volunteers of the same age and gender as patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sexual dysfunction</intervention_name>
    <description>Sexual dysfunction will be determined with separate scales for women and men</description>
    <arm_group_label>Group of Ankylosing Spondylitis</arm_group_label>
    <arm_group_label>Group of control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ankylosing spondylitis diagnosed by the rheumatologist&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being diagnosed with AS for individuals with AS,&#xD;
&#xD;
          -  No additional disease (comorbid and psychiatric disease, hypothyroidism,&#xD;
             hypopituitarism, hypogonadism or hyperprolactinemia)&#xD;
&#xD;
          -  Having a partner (relationship status in a monogamous sexual relationship),&#xD;
&#xD;
          -  Not smoking and drinking,&#xD;
&#xD;
          -  Non-AS partner have not been diagnosed with AS and their partner is AS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Overweight or obesity (BMI &lt;28 kg / m2)&#xD;
&#xD;
          -  Having had a pelvic injury, urological or gynecological operation in the last 3 months&#xD;
&#xD;
          -  Hypogonadism; penile abnormalities such as hypospadias, congenital curvature or&#xD;
             Peyronie's disease with preserved penis stiffness&#xD;
&#xD;
          -  Prostatic disorder&#xD;
&#xD;
          -  Use of drugs that may affect erectile function (steroids, antihistamines, ß-blockers&#xD;
             or SSRIs)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayse Ayan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Antalya Training and Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ayse Ayan, MD</last_name>
    <phone>+90 545 960 04 78</phone>
    <email>drayseayan@yahoo.com.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Antalya Tarining and Research Hospital Ethics Commitee</name>
      <address>
        <city>Antalya</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aysel Uysal, MD</last_name>
      <phone>+90 242 249 44 00-4217</phone>
      <email>etik.kurul.07@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Liu YF, Dong H, Chen Z, Wang YU, Tu SH. Impact of ankylosing spondylitis on sexual function: A systematic review and meta-analysis. Exp Ther Med. 2015 Apr;9(4):1501-1507. doi: 10.3892/etm.2015.2239. Epub 2015 Jan 29.</citation>
    <PMID>25780459</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Antalya Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ayse Ayan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ankylosing spondylitis</keyword>
  <keyword>sexual dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>there is a data to make individual participant data (IPD) available to other researchers.</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/NCT04411485
org study id: 2016-098
nct id: NCT04411485
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The adverse effects of rheumatologic diseases, especially Ankylosing Spondylitis (AS), on
      sexual functions are known. The causes of sexual dysfunction in rheumatologic diseases are
      due to factors such as pain, weakness, fatigue, stiffness, functional disability, anxiety,
      depression, hormonal deficiency, drug use, decreased libido and poor body image. Depending on
      these factors, sexual intercourse and frequency of sexual intercourse may decrease. Sexual
      dysfunction may be seen in AS due to physical and emotional problems caused by the disease.
There are many studies in the literature that determine sexual satisfaction and sexual
      dysfunction in individuals with AS and compare individuals with AS to healthy individuals .
      In the light of these studies, the investigators thought that the sexual function of partner
      of individuals with AS may also be affected negatively. In the literature, no previous study
      examines the sexual function of partner of individuals with AS. Therefore, the aim was to
      determine the sexual function of partner of individuals with AS and to compare with healthly
      adults of the same sex.
observational model: Case-Control
time perspective: Prospective
measure: Female Sexual Function Scale
time frame: 1 week
description: It is a Likert-type scale that evaluates sexual dysfunction in women consisting of 19 items. The validity and reliability study of FSFI was performed by Rosen et al. (8). The scale consists of six items: desire, arousal, lubrication, orgasm, sexual satisfaction and pain. Each title is scored between 0 or 1 to 6. The lowest score is two (2) and the highest score is thirty-six (36). A higher score means better function. Rosen et al. (2000) in their study of functional status; The FSFI score was classified as good if> 30, moderate between 23-29, and poor if <23 .
measure: International Erectile Function Form
time frame: 1 week
description: The questionnaire, which consists of 15 questions in total, determines the participants' erectile function, orgasmic function, sexual desire, sexual satisfaction and overall satisfaction and these 5 different sexual function areas are scored according to the answers received. It is a Likert type scale. As the score increases, it means that each area is good.
arm group label: Group of Ankylosing Spondylitis
description: Patient with ankylosing spondylitis diagnosed by a rheumatologist
arm group label: Group of control
description: Healthy volunteers of the same age and gender as patients
intervention type: Other
intervention name: Sexual dysfunction
description: Sexual dysfunction will be determined with separate scales for women and men
arm group label: Group of Ankylosing Spondylitis
arm group label: Group of control
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ayse Ayan, MD
role: Principal Investigator
affiliation: Antalya Training and Research Hospital
last name: Ayse Ayan, MD
phone: +90 545 960 04 78
email: drayseayan@yahoo.com.tr
facility: 
status: Recruiting
contact: 
country: Turkey
citation: Liu YF, Dong H, Chen Z, Wang YU, Tu SH. Impact of ankylosing spondylitis on sexual function: A systematic review and meta-analysis. Exp Ther Med. 2015 Apr;9(4):1501-1507. doi: 10.3892/etm.2015.2239. Epub 2015 Jan 29.
PMID: 25780459
responsible party type: Principal Investigator
investigator affiliation: Antalya Training and Research Hospital
investigator full name: Ayse Ayan
investigator title: Principal Investigator
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
sharing ipd: No
ipd description: there is a data to make individual participant data (IPD) available to other researchers.