Quantify the Degree of Pain Relief of Pelvic Congestion Syndrome Following Gonadal Vein Embolization
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Quantify pain relief using the Pelvic Congestion Symptom Pain Scale after gonadal vein embolization
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.
Time frame
Change from baseline (before gonadal vein embolization) to 360 days post-procedure.Secondary outcomes
1
Predict positive or poor response to gonadal vein embolization treatment
Identify clinical or imaging factors that are predictive of a positive response to treatment, or poor response to treatment.
Time frame
Change from baseline (before gonadal vein embolization) to 360 days post-procedure.Sponsors and contacts
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Source ClinicalTrials.gov