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

Last updated: April 11, 2025
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysmenorrhea (Painful Periods)

Treatment

N/A

Clinical Study ID

NCT03794466
STUDY00143045
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female patients 18 years of age or older

  • Meet the clinical and imaging criteria for the diagnosis of PCS and have nocontraindications to coil embolization of the gonadal veins.

  • Patients who are treated with coil embolization of the gonadal veins in theInterventional Radiology division between October 1, 2018 to October 1, 2019.

Exclusion

Exclusion Criteria:

  • Patients less than 18 years of age.

  • Patients who are found to have an underlying cause of pelvic congestion syndromeunrelated to venous congestion and insufficiency. This includes, but is not limitedto, nutcracker syndrome, or a mass resulting in extrinsic compression of the gonadalveins.

  • Patients who have received prior surgical therapy for PCS, including bilateralsalpingo-oophorectomy (TAH-BSO), gonadal vein resection, or gonadal vein ligation.

Study Design

Total Participants: 30
Study Start date:
May 10, 2019
Estimated Completion Date:
December 15, 2025

Study 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.

Connect with a study center

  • The University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

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