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

• ClinicalTrials.gov Identifier: NCT03794466
• Recruitment Status: Recruiting
• First Posted: January 7, 2019
• Last Update Posted: September 29, 2021
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): University of Kansas Medical Center

Study Description

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.

Condition or disease
Pelvic Congestive Syndrome; Pelvic Pain

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 Design

• Study Type: Observational
• Estimated Enrollment: 30 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Quantification of Pain Relief With Gonadal Vein Embolization for Pelvic Congestion Syndrome
• Actual Study Start Date: May 10, 2019
• Estimated Primary Completion Date: September 25, 2022
• Estimated Study Completion Date: September 25, 2023

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Females
• 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.

Criteria

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.

Contacts and Locations

Contacts

Contact: Carissa Walter, MPH; 9139457450; cwalter2@kumc.edu

Locations

United States, Kansas

The University of Kansas Medical Center; Recruiting

Kansas City, Kansas, United States, 66160

Contact: Carissa Walter, MPH 913-945-7450 cwalter2@kumc.edu

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

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

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

  Study Documents (Full-Text)

Documents provided by University of Kansas Medical Center:

Study Protocol  [PDF] December 6, 2018

More Information

Publications:

Ignacio EA, Dua R, Sarin S, Harper AS, Yim D, Mathur V, Venbrux AC. Pelvic congestion syndrome: diagnosis and treatment. Semin Intervent Radiol. 2008 Dec;25(4):361-8. doi: 10.1055/s-0028-1102998.

O'Brien MT, Gillespie DL. Diagnosis and treatment of the pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):96-106. doi: 10.1016/j.jvsv.2014.05.007. Epub 2014 Jun 25. Review.

Koo S, Fan CM. Pelvic congestion syndrome and pelvic varicosities. Tech Vasc Interv Radiol. 2014 Jun;17(2):90-5. doi: 10.1053/j.tvir.2014.02.005. Review.

Lopez AJ. Female Pelvic Vein Embolization: Indications, Techniques, and Outcomes. Cardiovasc Intervent Radiol. 2015 Aug;38(4):806-20. doi: 10.1007/s00270-015-1074-7. Epub 2015 Mar 25. Review.

Daniels JP, Champaneria R, Shah L, Gupta JK, Birch J, Moss JG. Effectiveness of Embolization or Sclerotherapy of Pelvic Veins for Reducing Chronic Pelvic Pain: A Systematic Review. J Vasc Interv Radiol. 2016 Oct;27(10):1478-1486.e8. doi: 10.1016/j.jvir.2016.04.016. Epub 2016 Jul 7. Review.

Brown CL, Rizer M, Alexander R, Sharpe EE 3rd, Rochon PJ. Pelvic Congestion Syndrome: Systematic Review of Treatment Success. Semin Intervent Radiol. 2018 Mar;35(1):35-40. doi: 10.1055/s-0038-1636519. Epub 2018 Apr 5. Review.

Guirola JA, Sánchez-Ballestin M, Sierre S, Lahuerta C, Mayoral V, De Gregorio MA. A Randomized Trial of Endovascular Embolization Treatment in Pelvic Congestion Syndrome: Fibered Platinum Coils versus Vascular Plugs with 1-Year Clinical Outcomes. J Vasc Interv Radiol. 2018 Jan;29(1):45-53. doi: 10.1016/j.jvir.2017.09.011. Epub 2017 Nov 22.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03794466
• Other Study ID Numbers: STUDY00143045
• First Posted: January 7, 2019
• Last Update Posted: September 29, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:

gonadal vein embolization

Additional relevant MeSH terms:

Syndrome; Pelvic Pain; Disease; Pathologic Processes; Pain; Neurologic Manifestations