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

Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03794466
• Other study ID #: STUDY00143045
• Status: Recruiting
• Start date: May 10, 2019
• Est. completion date: June 15, 2024

Study information

• Verified date: July 2023
• Source: University of Kansas Medical Center
• Contact: Carissa Walter, MPH
• Phone: 9139457450
• Email: cwalter2[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Congestive Syndrome
• Pelvic Pain
• Syndrome

Locations

Country	Name	City	State
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Predict positive or poor response to gonadal vein embolization treatment	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.