<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/NCT03794466</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00143045</org_study_id>
    <nct_id>NCT03794466</nct_id>
  </id_info>
  <brief_title>Quantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization</brief_title>
  <official_title>Quantification of Pain Relief With Gonadal Vein Embolization for Pelvic Congestion Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</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 primary objective is to quantify the degree of pain relief in patients undergoing gonadal&#xD;
      vein embolization with coils as well as identify clinical or imaging factors that are&#xD;
      predictive of a positive response to treatment, or poor response to treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pelvic pain affects almost 40% of women during their lifetime. Pelvic congestion&#xD;
      syndrome (PCS) accounts for up to 30% of those with chronic pelvic pain. The most common&#xD;
      underlying cause of PCS is incompetence or obstruction of the gonadal veins, resulting in&#xD;
      painful congestion of the pelvic and perineal venous vasculature. Medical treatment is first&#xD;
      line, and aims to suppress ovarian function and induce vasoconstriction of the venous system.&#xD;
      Unfortunately, efficacy and long-term pain relief from medical therapy is limited. Coil&#xD;
      embolization of the gonadal veins has been shown to decrease pain in those affected by PCS,&#xD;
      although the degree of relief has not yet been quantified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 10, 2019</start_date>
  <completion_date type="Anticipated">June 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quantify pain relief using the Pelvic Congestion Symptom Pain Scale after gonadal vein embolization</measure>
    <time_frame>Change from baseline (before gonadal vein embolization) to 360 days post-procedure.</time_frame>
    <description>quantify the degree of pain relief in patients undergoing gonadal vein embolization with coils using a survey consisting 4 questions. Answers will be given values 0-4, which higher values are considered to be worse outcomes. One question is &quot;On average, how many days a week do you experience pelvic pain?&quot; Answers would be none (0), 1-2 days a week (1), 3-4 days a week (2), 5-6 days a week (3), and every day of the week (4). Maximum total amount of points will be 16. This is the number of points added together from all 4 questions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predict positive or poor response to gonadal vein embolization treatment</measure>
    <time_frame>Change from baseline (before gonadal vein embolization) to 360 days post-procedure.</time_frame>
    <description>Identify clinical or imaging factors that are predictive of a positive response to treatment, or poor response to treatment.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pelvic Congestive Syndrome</condition>
  <condition>Pelvic Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Women, 18 years of age and older, who are candidates for gonadal vein embolization in the&#xD;
        Interventional Radiology division at the University of Kansas Medical Center from October&#xD;
        1, 2018 to October 1, 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients 18 years of age or older&#xD;
&#xD;
          -  Meet the clinical and imaging criteria for the diagnosis of PCS and have no&#xD;
             contraindications to coil embolization of the gonadal veins.&#xD;
&#xD;
          -  Patients who are treated with coil embolization of the gonadal veins in the&#xD;
             Interventional Radiology division between October 1, 2018 to October 1, 2019.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years of age.&#xD;
&#xD;
          -  Patients who are found to have an underlying cause of pelvic congestion syndrome&#xD;
             unrelated to venous congestion and insufficiency. This includes, but is not limited&#xD;
             to, nutcracker syndrome, or a mass resulting in extrinsic compression of the gonadal&#xD;
             veins.&#xD;
&#xD;
          -  Patients who have received prior surgical therapy for PCS, including bilateral&#xD;
             salpingo-oophorectomy (TAH-BSO), gonadal vein resection, or gonadal vein ligation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Females</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam S Alli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Kansas Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carissa Walter, MPH</last_name>
    <phone>9139457450</phone>
    <email>cwalter2@kumc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carissa Walter, MPH</last_name>
      <phone>913-945-7450</phone>
      <email>cwalter2@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Adam S Alli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel Kirkpatrick, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Steven Lemons, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brandon Custer, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philip Johnson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zachary Collins, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ignacio EA, Dua R, Sarin S, Harper AS, Yim D, Mathur V, Venbrux AC. Pelvic congestion syndrome: diagnosis and treatment. Semin Intervent Radiol. 2008 Dec;25(4):361-8. doi: 10.1055/s-0028-1102998.</citation>
    <PMID>21326577</PMID>
  </reference>
  <reference>
    <citation>O'Brien MT, Gillespie DL. Diagnosis and treatment of the pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):96-106. doi: 10.1016/j.jvsv.2014.05.007. Epub 2014 Jun 25.</citation>
    <PMID>26993690</PMID>
  </reference>
  <reference>
    <citation>Koo S, Fan CM. Pelvic congestion syndrome and pelvic varicosities. Tech Vasc Interv Radiol. 2014 Jun;17(2):90-5. doi: 10.1053/j.tvir.2014.02.005.</citation>
    <PMID>24840963</PMID>
  </reference>
  <reference>
    <citation>Lopez AJ. Female Pelvic Vein Embolization: Indications, Techniques, and Outcomes. Cardiovasc Intervent Radiol. 2015 Aug;38(4):806-20. doi: 10.1007/s00270-015-1074-7. Epub 2015 Mar 25.</citation>
    <PMID>25804635</PMID>
  </reference>
  <reference>
    <citation>Daniels JP, Champaneria R, Shah L, Gupta JK, Birch J, Moss JG. Effectiveness of Embolization or Sclerotherapy of Pelvic Veins for Reducing Chronic Pelvic Pain: A Systematic Review. J Vasc Interv Radiol. 2016 Oct;27(10):1478-1486.e8. doi: 10.1016/j.jvir.2016.04.016. Epub 2016 Jul 7.</citation>
    <PMID>27397619</PMID>
  </reference>
  <reference>
    <citation>Brown CL, Rizer M, Alexander R, Sharpe EE 3rd, Rochon PJ. Pelvic Congestion Syndrome: Systematic Review of Treatment Success. Semin Intervent Radiol. 2018 Mar;35(1):35-40. doi: 10.1055/s-0038-1636519. Epub 2018 Apr 5.</citation>
    <PMID>29628614</PMID>
  </reference>
  <reference>
    <citation>Guirola JA, Sanchez-Ballestin M, Sierre S, Lahuerta C, Mayoral V, De Gregorio MA. A Randomized Trial of Endovascular Embolization Treatment in Pelvic Congestion Syndrome: Fibered Platinum Coils versus Vascular Plugs with 1-Year Clinical Outcomes. J Vasc Interv Radiol. 2018 Jan;29(1):45-53. doi: 10.1016/j.jvir.2017.09.011. Epub 2017 Nov 22.</citation>
    <PMID>29174618</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gonadal vein embolization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03794466/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03794466
org study id: STUDY00143045
nct id: NCT03794466
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to quantify the degree of pain relief in patients undergoing gonadal
      vein embolization with coils as well as identify clinical or imaging factors that are
      predictive of a positive response to treatment, or poor response to treatment.
Chronic pelvic pain affects almost 40% of women during their lifetime. Pelvic congestion
      syndrome (PCS) accounts for up to 30% of those with chronic pelvic pain. The most common
      underlying cause of PCS is incompetence or obstruction of the gonadal veins, resulting in
      painful congestion of the pelvic and perineal venous vasculature. Medical treatment is first
      line, and aims to suppress ovarian function and induce vasoconstriction of the venous system.
      Unfortunately, efficacy and long-term pain relief from medical therapy is limited. Coil
      embolization of the gonadal veins has been shown to decrease pain in those affected by PCS,
      although the degree of relief has not yet been quantified.
observational model: Other
time perspective: Prospective
measure: Quantify pain relief using the Pelvic Congestion Symptom Pain Scale after gonadal vein embolization
time frame: Change from baseline (before gonadal vein embolization) to 360 days post-procedure.
description: quantify the degree of pain relief in patients undergoing gonadal vein embolization with coils using a survey consisting 4 questions. Answers will be given values 0-4, which higher values are considered to be worse outcomes. One question is "On average, how many days a week do you experience pelvic pain?" Answers would be none (0), 1-2 days a week (1), 3-4 days a week (2), 5-6 days a week (3), and every day of the week (4). Maximum total amount of points will be 16. This is the number of points added together from all 4 questions.
measure: Predict positive or poor response to gonadal vein embolization treatment
time frame: Change from baseline (before gonadal vein embolization) to 360 days post-procedure.
description: Identify clinical or imaging factors that are predictive of a positive response to treatment, or poor response to treatment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Females
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adam S Alli, MD
role: Principal Investigator
affiliation: The University of Kansas Medical Center
last name: Carissa Walter, MPH
phone: 9139457450
email: cwalter2@kumc.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
citation: Ignacio EA, Dua R, Sarin S, Harper AS, Yim D, Mathur V, Venbrux AC. Pelvic congestion syndrome: diagnosis and treatment. Semin Intervent Radiol. 2008 Dec;25(4):361-8. doi: 10.1055/s-0028-1102998.
PMID: 21326577
citation: O'Brien MT, Gillespie DL. Diagnosis and treatment of the pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):96-106. doi: 10.1016/j.jvsv.2014.05.007. Epub 2014 Jun 25.
PMID: 26993690
citation: Koo S, Fan CM. Pelvic congestion syndrome and pelvic varicosities. Tech Vasc Interv Radiol. 2014 Jun;17(2):90-5. doi: 10.1053/j.tvir.2014.02.005.
PMID: 24840963
citation: Lopez AJ. Female Pelvic Vein Embolization: Indications, Techniques, and Outcomes. Cardiovasc Intervent Radiol. 2015 Aug;38(4):806-20. doi: 10.1007/s00270-015-1074-7. Epub 2015 Mar 25.
PMID: 25804635
citation: Daniels JP, Champaneria R, Shah L, Gupta JK, Birch J, Moss JG. Effectiveness of Embolization or Sclerotherapy of Pelvic Veins for Reducing Chronic Pelvic Pain: A Systematic Review. J Vasc Interv Radiol. 2016 Oct;27(10):1478-1486.e8. doi: 10.1016/j.jvir.2016.04.016. Epub 2016 Jul 7.
PMID: 27397619
citation: Brown CL, Rizer M, Alexander R, Sharpe EE 3rd, Rochon PJ. Pelvic Congestion Syndrome: Systematic Review of Treatment Success. Semin Intervent Radiol. 2018 Mar;35(1):35-40. doi: 10.1055/s-0038-1636519. Epub 2018 Apr 5.
PMID: 29628614
citation: Guirola JA, Sanchez-Ballestin M, Sierre S, Lahuerta C, Mayoral V, De Gregorio MA. A Randomized Trial of Endovascular Embolization Treatment in Pelvic Congestion Syndrome: Fibered Platinum Coils versus Vascular Plugs with 1-Year Clinical Outcomes. J Vasc Interv Radiol. 2018 Jan;29(1):45-53. doi: 10.1016/j.jvir.2017.09.011. Epub 2017 Nov 22.
PMID: 29174618
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Pelvic Pain
sharing ipd: No
provided document: 