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

March 18, 2026 updated by: University of Kansas Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Adam S Alli, MD
        • Sub-Investigator:
          • Daniel Kirkpatrick, MD
        • Sub-Investigator:
          • Steven Lemons, MD
        • Sub-Investigator:
          • Brandon Custer, MD
        • Sub-Investigator:
          • Philip Johnson, MD
        • Sub-Investigator:
          • Zachary Collins, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (before gonadal vein embolization) to 360 days post-procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (before gonadal vein embolization) to 360 days post-procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Adam S Alli, MD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00143045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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