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

University of Kansas

Status: Enrolling

Conditions: Pelvic Pain; Pelvic Congestive Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT03794466

STUDY00143045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design