<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/NCT04415710</url>
  </required_header>
  <id_info>
    <org_study_id>2019-166</org_study_id>
    <nct_id>NCT04415710</nct_id>
  </id_info>
  <brief_title>Pelvic Floor and Sexual Dysfunction in Women With Sjogren's Syndrome</brief_title>
  <official_title>Investigation of the Relationship Between the Pelvic Floor and Sexual Dysfunction in Women With Sjogren's Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akdeniz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akdeniz University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by&#xD;
      lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is&#xD;
      more common in women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sexual functions are affected by symptoms such as pain, fatigue, stiffness, and hormonal&#xD;
      imbalance in rheumatological disorders. Vaginal dryness and dyspepsia negatively affect&#xD;
      participation in sexual activity. The aim of the study is to examine the pelvic floor&#xD;
      problems of women with SS with a self-report, to compare them with healthy individuals, and&#xD;
      finally to examine the relationship between pelvic floor problems and sexual dysfunction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">June 2, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Pelvic Floor Distress Inventory PFDI-20</measure>
    <time_frame>1 week</time_frame>
    <description>Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Each short-form scale demonstrates significant correlation with their long-form scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic Floor Impact Questionnaire PFIQ</measure>
    <time_frame>1 week</time_frame>
    <description>Pelvic Floor Impact Questionnaire (PFIQ): The questionnaire has 7 questions and each question has 3 separate responses. The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7. The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Female Sexual Dysfunction Index FSFI</measure>
    <time_frame>1 week</time_frame>
    <description>The FSFI is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">94</enrollment>
  <condition>Sexual Dysfunction</condition>
  <condition>Pelvic Floor Disorders</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Urinary Incontinence</condition>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Group</arm_group_label>
    <description>Women with diagnosed Sjogren syndrome</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        94 women with Sjögren syndrome with an average age of 48.15 ± 8.73 years were included in&#xD;
        the study. 94 women diagnosed as SS according to 2016 ACR-EULAR Classification Criteria for&#xD;
        primary Sjögren's syndrome were included in the study by Rheumatology Clinic of Hospital.&#xD;
        Ethical approval of the study was obtained from the Interventional Clinical Research Ethics&#xD;
        Committee. All women were informed verbally and informed consent forms were signed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being between the ages of 18-65&#xD;
&#xD;
          -  being a woman,&#xD;
&#xD;
          -  having sex partner,&#xD;
&#xD;
          -  no smoking, no alcohol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  physical, psychological, cognitive impairment,&#xD;
&#xD;
          -  having a non-Sjögren additional disease,&#xD;
&#xD;
          -  malignancy,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  no urogenital disease,&#xD;
&#xD;
          -  sarcoidosis,&#xD;
&#xD;
          -  AIDS,&#xD;
&#xD;
          -  anticholinergic drug use,&#xD;
&#xD;
          -  had a gynecological or urological operation other than cesarean&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ayse Ayan</last_name>
    <role>Study Director</role>
    <affiliation>University of Health Sciences Antalya Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ayse Ayan</name>
      <address>
        <city>Antalya</city>
        <zip>07059</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjogren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4.</citation>
    <PMID>25652072</PMID>
  </reference>
  <results_reference>
    <citation>Budden AK, Te West NI, Sturgess AD, Moore KH. Pelvic floor dysfunction in female Sjogren's syndrome: an 8-year audit. Int Urogynecol J. 2016 Sep;27(9):1367-73. doi: 10.1007/s00192-016-2985-9. Epub 2016 Mar 10.</citation>
    <PMID>26965411</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 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>Akdeniz University</investigator_affiliation>
    <investigator_full_name>Alime Buyuk</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <keyword>pelvic pain</keyword>
  <keyword>sexual dysfunction</keyword>
  <keyword>unirary incontinence</keyword>
  <keyword>constipation</keyword>
  <keyword>pelvic floor dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Pelvic Floor Disorders</mesh_term>
    <mesh_term>Constipation</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <!-- 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/NCT04415710
org study id: 2019-166
nct id: NCT04415710
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by
      lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is
      more common in women.
Sexual functions are affected by symptoms such as pain, fatigue, stiffness, and hormonal
      imbalance in rheumatological disorders. Vaginal dryness and dyspepsia negatively affect
      participation in sexual activity. The aim of the study is to examine the pelvic floor
      problems of women with SS with a self-report, to compare them with healthy individuals, and
      finally to examine the relationship between pelvic floor problems and sexual dysfunction.
observational model: Cohort
time perspective: Prospective
measure: Pelvic Floor Distress Inventory PFDI-20
time frame: 1 week
description: Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Each short-form scale demonstrates significant correlation with their long-form scales
measure: Pelvic Floor Impact Questionnaire PFIQ
time frame: 1 week
description: Pelvic Floor Impact Questionnaire (PFIQ): The questionnaire has 7 questions and each question has 3 separate responses. The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7. The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100.
measure: Female Sexual Dysfunction Index FSFI
time frame: 1 week
description: The FSFI is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.
arm group label: Group
description: Women with diagnosed Sjogren syndrome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
last name: Ayse Ayan
role: Study Director
affiliation: University of Health Sciences Antalya Training and Research Hospital
facility: 
country: Turkey
citation: van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjogren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4.
PMID: 25652072
citation: Budden AK, Te West NI, Sturgess AD, Moore KH. Pelvic floor dysfunction in female Sjogren's syndrome: an 8-year audit. Int Urogynecol J. 2016 Sep;27(9):1367-73. doi: 10.1007/s00192-016-2985-9. Epub 2016 Mar 10.
PMID: 26965411
responsible party type: Principal Investigator
investigator affiliation: Akdeniz University
investigator full name: Alime Buyuk
investigator title: PhD Student
mesh term: Sjogren's Syndrome
mesh term: Urinary Incontinence
mesh term: Pelvic Floor Disorders
mesh term: Constipation
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse