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

NCT03794466 | Recruiting

• 1 other identifier: STUDY00143045
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Pelvic Congestive Syndrome

Keywords

gonadal vein embolization

Outcome Measures

Primary Outcomes (1)

• Quantify pain relief using the Pelvic Congestion Symptom Pain Scale after gonadal vein embolization

  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 Outcomes (1)

• Predict positive or poor response to gonadal vein embolization treatment

  Change from baseline (before gonadal vein embolization) to 360 days post-procedure.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 21326577 BACKGROUND

• 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.

  PMID: 26993690 BACKGROUND

• 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.

  PMID: 24840963 BACKGROUND

• 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.

  PMID: 25804635 BACKGROUND

• 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.

  PMID: 27397619 BACKGROUND

• 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.

  PMID: 29628614 BACKGROUND

• Guirola JA, Sanchez-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.

  PMID: 29174618 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam S Alli, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carissa Walter, MPH

CONTACT

9139457450; cwalter2@kumc.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 7, 2019
• Study Start: May 10, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)