Pelvic Puzzle
By Rebecca Montz, EdD, MBA, CNMT, PET, RT(N)(CT), NMTCB RS
Radiology Today
Vol. 25 No. 5 P. 14

Understanding unexplained pain with the EMBOLIZE trial.

Many women endure perplexing pelvic discomfort, which can persist for months or even years, while health care providers work to uncover its root causes. This unexplained pain can profoundly affect a woman’s quality of life and may stem from various underlying factors. Pelvic pain is a prevalent condition affecting a significant percentage of women, with estimates suggesting it affects as many as one in six women in the United States. While numerous conditions can trigger pelvic pain, pelvic venous disorder (PeVD) may account for pain in up to 30% of women experiencing pelvic discomfort.

PeVD includes a range of conditions characterized by abnormalities in the veins of the pelvis, previously called pelvic congestion syndrome, with dilated pelvic varices being a common source. PeVD manifests when pelvic veins become swollen and engorged with blood, resulting in discomfort and pain. The precise cause of PeVD is not always evident, but it is thought to be linked to issues with vein valves, leading to blood accumulation and heightened pressure in the pelvic region. Diagnosing PeVD can pose challenges due to symptom overlaps with other pelvic conditions. Imaging modalities such as ultrasound, CT, or MRI are typically employed to visualize pelvic veins and detect irregularities. In some cases, a venogram may be necessary for detailed imaging and source determination.

Estimates of PeVD prevalence vary widely, ranging from 4% to 62% across multiple studies, reflecting diagnostic challenges and symptom variability among affected individuals. These findings underscore the importance of recognizing and managing chronic pelvic pain in women through comprehensive, multidisciplinary care to enhance outcomes and quality of life. The recent introduction of the groundbreaking clinical trial, EMBOLIZE, presents a promising opportunity to tackle the perplexing issue of PeVD and alleviate unexplained pelvic pain in women.

The EMBOLIZE trial represents a collaborative initiative that is being sponsored by several prominent medical societies: the Society of Interventional Radiology (SIR) Foundation, The Vascular InterVentional Advances (VIVA) Foundation, and Penumbra, Inc. Leading this investigatorinitiated clinical endeavor are Ronald S.

Winokur, MD, FSIR, a professor of clinical radiology at Weill Cornell Medicine in New York, and Gloria Salazar, MD, FSIR, an associate professor of radiology at the University of North Carolina at Chapel Hill. They will serve as the national coprincipal investigators. A steering committee has been established to oversee the trial’s administration and ensure procedural integrity. Comprising a multidisciplinary panel of physician researchers specializing in PeVD, including interventional radiologists and vascular surgeons, the steering committee also includes representatives from each funding entity.

Winokur says the study will play a pivotal role in amassing comprehensive data pertaining to women afflicted by chronic pelvic pain of venous origin. By thoroughly gathering and analyzing this data, the study aspires to facilitate more accurate identification of patients and provide invaluable guidance in determining optimal treatment or assessment strategies tailored to individual needs. Winokur anticipates that the study will be successful, thus facilitating a transformative enhancement in the quality of life for women suffering from chronic pelvic pain.

Upon completion of the study, a thorough reassessment will be conducted to evaluate the outcomes and discern whether further exploration of alternative interventions is warranted. This evaluation process underscores the study’s commitment to continuous improvement and innovation, ensuring that emerging insights are leveraged to refine treatment approaches and elevate standards of care for individuals suffering with chronic pelvic pain of venous origin. The researchers are hoping that the study will pave the way for a future where every patient receives personalized, evidence-based interventions tailored to their unique needs, thereby fostering optimal outcomes and improved quality of life.

Open Enrollment
The EMBOLIZE trial offers hope for women in search of effective relief from PeVD. According to Salazar, PeVD typically affects women who have undergone pregnancy, leading to the pooling of blood flow in the ovarian and pelvic veins, akin to varicose veins in the legs. The groundbreaking study aims to recruit women aged 18 and above exhibiting dilated pelvic veins in the periuterine and periovarian space.

“The EMBOLIZE trial will be a rigorous, well-powered, patient-blinded comparison of venography and venography plus embolization and will use pain scores and patient-reported outcome measures to determine the benefit of embolization in this population,” Salazar says.

With a target enrollment of 40 patients across up to five sites in the United States, the trial is scheduled to span 24 months. The primary objective of EMBOLIZE is to assess the efficacy of venography followed by bilateral ovarian vein and pelvic vein embolization compared with venography alone in women manifesting symptoms and signs indicative of venous-origin chronic pelvic pain. Pain scores, evaluated on a visual analog scale, will be tracked from four weeks prior to treatment through six months posttreatment to ascertain changes. Additionally, investigators will analyze improvements in quality of life, alterations in pelvic vein varices, and modifications in pain medication usage, Salazar says.

The innovative trial marks the inaugural collection of randomized controlled data on ovarian vein embolization (OVE) for ovarian vein reflux and pelvic varicose veins. This pivotal research endeavor is poised to significantly advance the identification and treatment of all patients grappling with chronic pelvic pain of venous origin. Looking ahead, continued data collection over extended time intervals after treatment or future interventions promises to refine access to care for this vulnerable patient population, Winokur notes.

Overcoming Barriers
Identifying potential candidates for the EMBOLIZE trial poses a significant challenge due to the complexities involved in diagnosing PeVD. Winokur says many gynecologists and specialists in pelvic pain are unaware of PeVD’s potential contribution to pelvic pain in certain patients. As a result, women suffering from PeVD often experience chronic pelvic pain without proper diagnosis or treatment, and lack of awareness presents obstacles in identifying all eligible patients who could benefit from treatment.

This oversight persists due to the absence of clinical trials comparing the efficacy of pelvic vein embolization with alternative treatments or no treatment. Consequently, PeVD remains overlooked by specialists, resulting in suboptimal care for affected patients, Winokur says. Furthermore, PeVD treatments for women are not universally covered by insurance, further perpetuating the under-recognition and undertreatment of the condition.

In addition to the challenges of symptom awareness and diagnostic complexities associated with PeVD, there are limitations in treatment options and significant research gaps. The lack of awareness can lead to underdiagnosis and potential misdiagnosis; diagnosing PeVD is challenging due to symptom overlap with other pelvic conditions and the absence of specific diagnostic tests. Consequently, delays in diagnosis and treatment can occur.

Treatment options for PeVD are often restricted and may vary based on symptom severity and individual patient factors. While conservative approaches such as pain management and lifestyle adjustments are commonly recommended, more invasive interventions like surgery or minimally invasive procedures may be necessary in certain cases. Furthermore, PeVD treatments for women are not universally covered by insurance, perpetuating the under-recognition and undertreatment of the condition.

Addressing Research Gaps
Further research is crucial to enhance diagnostic accuracy, refine treatment strategies, and optimize patient outcomes. Previous research indicates that embolization is both safe and effective, with 75% to 90% of women experiencing sustained relief from chronic pelvic pain attributed to venous causes. However, there is a notable gap in clinical trials: none have directly compared the outcomes of women treated with embolization with those who received no treatment.

“It is critical to increase research and awareness of incorrectly diagnosed chronic pelvic pain, and EMBOLIZE will help us obtain the robust evidence needed to close the significant gaps in research to allow for disease-specific recognition to guide optimal treatment,” Winokur says.

Salazar notes that the trial aims to address the research gaps by conducting such a comparison while also implementing a blinded approach where patients are unaware of whether they underwent vein closure or not. This approach will provide valuable evidence regarding the efficacy of OVE in alleviating significant pelvic pain.

Maureen P. Kohi, MD, FSIR, who serves as the chair of the SIR Foundation and is a member of the VIVA Foundation board of directors, is an interventional radiologist and chairs the department of radiology at the University of North Carolina Chapel Hill. She says, “This study will solidify the role of OVE in the treatment of women experiencing pain from pelvic venous disease and will also provide the evidence needed to ensure insurance coverage for these treatments.”

The EMBOLIZE study strives to confront the multifaceted challenges associated with chronic pelvic pain by revealing the substantial benefits of pelvic venous embolization specifically tailored for women afflicted by pelvic varicose veins. Through meticulous examination and rigorous analysis, this study aims not only to unveil the therapeutic advantages of such interventions but also to collect compelling evidence essential for advocating for broader insurance coverage. By advocating for insurance coverage of these treatments, the researchers hope to dismantle barriers to access and ensure equitable availability for all women dealing with chronic pelvic pain attributed to pelvic varicose veins. Through these concerted efforts, they endeavor to catalyze a paradigm shift in the landscape of pelvic pain management, fostering a future where every woman in need can access timely and effective interventions, thereby enhancing their quality of life and overall well-being.

Future Insights
For women living with pelvic pain, each day can be a challenging journey filled with discomfort and uncertainty, but the EMBOLIZE trial provides a reason for hope. Salazar’s outlook is optimistic. “We strongly believe the data generated by this study will enhance the quality of life of patients around the world who are affected by pelvic venous disorders,” she says. Through the collective endeavors of those spearheading the trial, there is a tangible sense of anticipation for significant strides and relief for those dealing with PeVD.

The EMBOLIZE trial offers a promising pathway for women to obtain the treatment they need to alleviate their suffering and elevate their overall quality of life. However, the realization of this transformative potential hinges on the cultivation of heightened awareness among health care professionals and the broader public regarding PeVD. It is imperative that PeVD gains widespread recognition and understanding to enable early detection and effective management strategies. By fostering a deeper understanding of this condition, individuals can be empowered to seek timely intervention, thus ensuring improved outcomes and enhanced wellbeing for those affected by PeVD.

Rebecca Montz, EdD, MBA, CNMT, PET, RT(N) (CT), NMTCB RS, has worked at the Mayo Clinic Jacksonville and University of Texas MD Anderson Cancer Center in Houston as a nuclear medicine and PET technologist.