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Trial record 63 of 69 for:    ORLISTAT

Quantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization

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ClinicalTrials.gov Identifier: NCT03794466
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
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.

Condition or disease
Pelvic Congestive Syndrome Pelvic Pain

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Quantification of Pain Relief With Gonadal Vein Embolization for Pelvic Congestion Syndrome
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : September 25, 2020
Estimated Study Completion Date : September 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain




Primary Outcome Measures :
  1. 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. ]
    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.


Secondary Outcome Measures :
  1. Predict positive or poor response to gonadal vein embolization treatment [ Time Frame: Change from baseline (before gonadal vein embolization) to 360 days post-procedure. ]
    Identify clinical or imaging factors that are predictive of a positive response to treatment, or poor response to treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women, 18 years of age and older, who are candidates for gonadal vein embolization in the Interventional Radiology division at the University of Kansas Medical Center from October 1, 2018 to October 1, 2019.
Criteria

Inclusion Criteria:

  • Female patients 18 years of age or older
  • Meet the clinical and imaging criteria for the diagnosis of PCS and have no contraindications to coil embolization of the gonadal veins.
  • Patients who are treated with coil embolization of the gonadal veins in the Interventional Radiology division between October 1, 2018 to October 1, 2019.

Exclusion Criteria:

  • Patients less than 18 years of age.
  • Patients who are found to have an underlying cause of pelvic congestion syndrome unrelated to venous congestion and insufficiency. This includes, but is not limited to, nutcracker syndrome, or a mass resulting in extrinsic compression of the gonadal veins.
  • Patients who have received prior surgical therapy for PCS, including bilateral salpingo-oophorectomy (TAH-BSO), gonadal vein resection, or gonadal vein ligation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794466


Contacts
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Contact: Carissa Walter, MPH 9139457450 cwalter2@kumc.edu

Locations
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United States, Kansas
The University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Carissa Walter, MPH    913-945-7450    cwalter2@kumc.edu   
Principal Investigator: Adam S Alli, MD         
Sub-Investigator: Daniel Kirkpatrick, MD         
Sub-Investigator: Steven Lemons, MD         
Sub-Investigator: Brandon Custer, MD         
Sub-Investigator: Philip Johnson, MD         
Sub-Investigator: Zachary Collins, MD         
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Adam S Alli, MD The University of Kansas Medical Center
  Study Documents (Full-Text)

Documents provided by University of Kansas Medical Center:
Study Protocol  [PDF] December 6, 2018


Publications:

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03794466     History of Changes
Other Study ID Numbers: STUDY00143045
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
gonadal vein embolization
Additional relevant MeSH terms:
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Syndrome
Pelvic Pain
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms