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NCT Number: NCT03794466

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Adam S Alli, MD

PRINCIPAL_INVESTIGATOR

Brandon Custer, MD

SUB_INVESTIGATOR

Carissa Walter, MPH

CONTACT

[email protected]

913-945-7450

Daniel Kirkpatrick, MD

SUB_INVESTIGATOR

Philip Johnson, MD

SUB_INVESTIGATOR

Steven Lemons, MD

SUB_INVESTIGATOR

Zachary Collins, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carissa Walter, MPH

CONTACT

[email protected]

9139457450

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2019
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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