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

Quantification of Pain Relief With Gonadal Vein Embolization for Pelvic Congestion Syndrome

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03794466

Enrollment

Registered

2019-01-07

Start date

2019-05-10

Completion date

2027-12-31

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Congestive Syndrome, Pelvic Pain

Keywords

gonadal vein embolization

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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Quantify pain relief using the Pelvic Congestion Symptom Pain Scale after gonadal vein embolization	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

Measure	Time frame	Description
Predict positive or poor response to gonadal vein embolization treatment	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.

Countries

United States

Contacts

CONTACTCarissa Walter, MPH

cwalter2@kumc.edu9139457450

PRINCIPAL_INVESTIGATORAdam S Alli, MD

University of Kansas Medical Center

Outcome results