Quantification of Pain Relief With Gonadal Vein Embolization for Pelvic Congestion Syndrome
Conditions: Pelvic Congestive Syndrome, Pelvic Pain
Sponsor: University of Kansas Medical Center

 
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Quantification of Pain Relief with Gonadal Vein Embolization for Pelvic Congestion 
Syndrome 
 
December 6, 2018 
 
 
Investigators 
Daniel L Kirkpatrick MD (Trainee), Adam Alli MD (PI/Mentor), Zachary Collins MD (Mentor), 
Carissa Walter MPH (Research Manager). Department of Radiology. 
 
Purpose of Project 
To quantify the degree of pain relief following gonadal vein embolization. 
 
Background 
Chronic pelvic pain, defined as lower abdominal or pelvic pain lasting for greater than 3-6 
months, affects almost 40% of women during their lifetime.1,2 Pelvic congestion syndrome (PCS) 
accounts for up to 30% of those with chronic pelvic pain, and is characterized by pelvic pain, 
dyspareunia, dysuria, and dysmenorrhea.1,2 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.2.3 
 
Medical treatment is first line, and aims to suppress ovarian function and induce 
vasoconstriction of the venous system.1,2 The most common medications used are 
medroxyprogesterone acetate (MPA) or the GnRH analogue goserelin, although this often 
necessitates estrogen replacement therapy to counteract the symptoms of ovarian 
suppression.1 Unfortunately, efficacy and long-term pain relief from medical therapy is limited.2 
 
Invasive options include total abdominal hysterectomy and bilateral salpingo-oophorectomy 
(TAH-BSO), extraperitoneal gonadal vein resection, and laparoscopic gonadal vein ligation.1,2 
Efficacy of TAH-BSO is poor, with 33% of patients reporting residual pain, and 20% reporting 
recurrent pain.1 Gonadal vein resection and ligation have shown positive results, although are 
more invasive, and result in longer hospital stays, and have higher complication rates.2 
 
Since its development in the early nineties, gonadal vein embolization has become the 
treatment of choice.1,2 A number of studies have reported pain relief ranging between 47 to 94% 
of patients, that has been maintained through up to 36 months of follow up.2 Complications are 
rare, and include gonadal vein perforation, coil migration, and recurrent varices.1,2 The 
procedure involves obtaining venous access, performing venography of the gonadal veins, and 
subsequently embolizing one or both gonadal veins. Multiple embolic agents have been 
demonstrated in the literature, including liquid sclerosants (such as sodium tetradecyl sulfate, 
polidocanol), glue (such as n-butyl cyanoacrylate), Amplatzer plugs, and coils.1-4 
 
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.5-7 This study’s primary aim is to 
quantify the degree of pain relief with gonadal vein embolization. A patient questionnaire, called 
the Pelvic Congestion Symptom Score (PCSS) has been developed specifically for this project.  
 

 
2 
The PCSS is a 4-question tool used for evaluation of PCS symptoms both before and after 
gonadal vein embolization. It encompasses symptom frequency, severity, impact on activities, 
as well as happiness and quality of life, with scores ranging from 0 (asymptomatic) to 16 
(disabled). Data gathered from the PCSS will help identify the degree of relief from PCS 
symptoms, as well as identify patients who are treatment resistant. Patients with no response or 
incomplete response to therapy will be further studied to identify predictors of ineffective 
treatment, possibly identifying patients who would benefit from more aggressive treatment. 
 
Methods 
This prospective study will enroll a maximum of 30 patients 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. Following clinical 
evaluation, the patients will fill out the PCSS survey prior to their procedure. Patients will then fill 
out the same PCSS survey at 4 weeks, 90 days, 180 days, and 360 days following their 
procedure. Follow up surveys will either be performed by phone or at a relevant follow up 
appointment. Relevant clinical information will be obtained from patients’ medical records and 
the Picture Archiving and Communication System (PACS), including demographics, clinical 
history, imaging findings, and intervention details. Secondary analysis will be performed to 
determine whether there are clinical or imaging factors that are predictive of a positive response 
to treatment, or poor response to treatment. 
 
Specific Objectives 
• 
Null Hypothesis: There is no significant difference in chronic pelvic pain following gonadal 
vein embolization, and/or the PCSS is an invalid tool for grading symptomatic improvement 
following gonadal vein embolization. 
• 
Primary Objective: To quantify the degree of pain relief in patients undergoing gonadal 
vein embolization with coils. 
• 
Secondary Objective: To identify clinical or imaging factors that are predictive of a positive 
response to treatment, or poor response to treatment. 
 
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. 
 
Risks 
As the primary objective of this study is to quantify improvement in patient pain following 
gonadal vein embolization via the use of the PCSS questionnaire, there are no expected risks to 
be incurred by patients participating in this study. 
 

 
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Statistical Analysis 
Descriptive statistics, correlations, and multivariate linear and/or logistic regression models will 
be utilized to analyze the data by trained professionals in the Radiology and/or Biostatistics 
Departments at KUMC.  
 
Data Management 
Data collection forms will be created and managed in REDCap. Patient information will be kept 
in password-protected databases and will be deidentified for analyses and presentations of 
results. All study documents will be stored on limited access KUMC protected network drives 
and any paper copies of source documents will be locked in the Radiology Research Office. 
 
References 
1. Ignacio EA, et al. Pelvic Congestion Syndrome: Diagnosis and Treatment. Semin Intervent 
Radiol 2008; 25(4):361–368. 
2. O'Brien MT, Gillespie DL. Diagnosis And Treatment Of The Pelvic Congestion Syndrome. J 
Vasc Surg Venous Lymphat Disord 2015; 3(1):96-106. 
3. Koo S, Fan CM. Pelvic Congestion Syndrome And Pelvic Varicosities. Tech Vasc Interv 
Radiol 2014; 17(2):90-95. 
4. Lopez AJ. Female Pelvic Vein Embolization: Indications, Techniques, and Outcomes. 
Cardiovasc Intervent Radiol 2015; 38(4):806–820. 
5. 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; 27(10):1478-1486. 
6. Brown CL, Rizer M, Alexander R, Sharpe EE 3rd, Rochon PJ. Pelvic Congestion Syndrome: 
Systematic Review Of Treatment Success. Semin Intervent Radiol 2018; 35(1):35-40. 
7. 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; 29(1):45-53. 
 
 
 

 
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Table Outlines 
 
Table 1: Patient Characteristics 
• 
Demographics 
o Age (mean, SD) 
o Race (n, %): White, Black or African American, Asian, American Indian or Alaska 
Native, Native Hawaiian or Other Pacific Islander, Other / Unspecified 
o Ethnicity (n, %): Hispanic, Non-Hispanic 
o Height (mean, SD) 
o Weight (mean, SD) 
o Parity (mean, SD) 
• 
Symptoms 
o Dyspareunia (mean, SD) 
o Dysuria (mean, SD) 
o Dysmenorrhea (mean, SD) 
• 
Presence of Varicosities 
o Unilateral Gluteal (mean, SD) 
o Bilateral Gluteal (mean, SD) 
o Unilateral Vulvar (mean, SD) 
o Bilateral Vulvar (mean, SD) 
o Unilateral Perineal (mean, SD) 
o Bilateral Perineal (mean, SD) 
o Unilateral Upper-Inner Thigh (mean, SD) 
o Bilateral Upper-Inner Thigh (mean, SD) 
 
Table 2: Imaging and Intervention Characteristics 
• 
Right Gonadal Vein Diameter (mm, SD) 
• 
Left Gonadal Vein Diameter (mm, SD) 
• 
Right Internal Iliac Vein Diameter (mm, SD) 
• 
Left Internal Iliac Vein Diameter (mm, SD) 
• 
Side of Intervention (n, %): Left, Right, Bilateral 
• 
Number of Coils Used Per Side (n, %) 
 
Table 3: Pain Scores 
• 
Pre-Intervention 
o Number of Days a Week Pelvic Pain is Experienced (mean, SD) 
o Severity of Pelvic Pain (mean, SD) 
o Limitation from Pelvic Pain (mean, SD) 
o Effect on Happiness and/or Quality of Life (mean, SD) 
o Total Score (mean, SD) 
• 
4 Weeks Post-Intervention 
o Number of Days a Week Pelvic Pain is Experienced (mean, SD) 
o Severity of Pelvic Pain (mean, SD) 
o Limitation from Pelvic Pain (mean, SD) 
o Effect on Happiness and/or Quality of Life (mean, SD) 
o Total Score (mean, SD) 
• 
90 Days Post-Intervention 
o Number of Days a Week Pelvic Pain is Experienced (mean, SD) 
o Severity of Pelvic Pain (mean, SD) 
o Limitation from Pelvic Pain (mean, SD) 

 
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o Effect on Happiness and/or Quality of Life (mean, SD) 
o Total Score (mean, SD) 
• 
180 Days Post-Intervention 
o Number of Days a Week Pelvic Pain is Experienced (mean, SD) 
o Severity of Pelvic Pain (mean, SD) 
o Limitation from Pelvic Pain (mean, SD) 
o Effect on Happiness and/or Quality of Life (mean, SD) 
o Total Score (mean, SD) 
• 
360 Days Post-Intervention 
o Number of Days a Week Pelvic Pain is Experienced (mean, SD) 
o Severity of Pelvic Pain (mean, SD) 
o Limitation from Pelvic Pain (mean, SD) 
o Effect on Happiness and/or Quality of Life (mean, SD) 
o Total Score (mean, SD) 
 
Table 4: Primary Outcomes 
• 
Mean Reduction of Pain Score 4 Weeks Post-Procedure (Mean, SD) 
• 
Mean Reduction of Pain Score 90 Days Post-Procedure (Mean, SD) 
• 
Mean Reduction of Pain Score 180 Days Post-Procedure (Mean, SD) 
• 
Mean Reduction of Pain Score 360 Post-Procedure (Mean, SD)