Embolization of Ovarian Vein and Pelvic Venous Reservoir for Treatment of Secondary Pelvic Congestion Syndrome

NCT07472504 | Not Yet Recruiting

• 1 other identifier: Pelvic congestion Syndrome
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Transcatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir for Treatment of Pelvic Congestion Syndrome Secondary to May-Thurner Syndrome. This study aims to prospectively evaluate the short-term clinical outcomes and the incidence of post-embolization stenting for residual symptoms.

Conditions

Pelvic Congestion Syndrome

Outcome Measures

Primary Outcomes (2)

• Change in pelvic pain severity using VAS pain score as scale

  The primary outcome measure is designed to assess the significant reduction in pelvic pain severity which is defined as a ≥ 50% reduction in the VAS pain score from baseline to post-procedure at 1, 3, 6, 9 and 12 months post-procedure. Alternatively, a patient-reported VAS score of ≤ 3 at the same intervals post-procedure may also be considered a successful outcome, representing mild or no pain Improvement in Specific PCS Symptoms: Assessment of individual PCS symptoms (e.g., dyspareunia, dysmenorrhea, post-coital pain, pelvic heaviness, lower extremity pain/edema) using validated symptom scales such as Pelvic Venous Clinical Severity Score (PVCSS) (e.g., categorical improvement: complete resolution, significant improvement, mild improvement, no change, worsening

  12 months

• The primary outcome measure is designed to assess the significant reduction in pelvic pain severity

  The primary outcome measure is designed to assess the significant reduction in pelvic pain severity which is defined as a ≥ 50% reduction in the VAS pain score from baseline to post-procedure at 1, 3, 6, 9 and 12 months post-procedure. Alternatively, a patient-reported VAS score of ≤ 3 at the same intervals post-procedure may also be considered a successful outcome, representing mild or no pain.

  12 months

Study Arms (1)

Adult Females with secondary pelvic congestion syndrome due to May thurner syndrome

EXPERIMENTAL

Procedure: embolization therapy

Interventions

embolization therapy PROCEDURE

Transcatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir

Adult Females with secondary pelvic congestion syndrome due to May thurner syndrome

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult females aged 18 -60 years.
• Clinical symptoms consistent with PCS \>6 months refractory to conservative treatment(e.g., chronic pelvic pain (CPP) of at least 6 months duration, unresponsive to conventional pain management strategies and worsening with standing, dyspareunia, pelvic heaviness, presence of vulvar/perineal/thigh varices and ovarian point tenderness during examination in patients with history of post-coital pain).
• Imaging-confirmed non-thrombotic iliac venous outflow stenosis or occlusion with ovarian and/or pelvic venous reservoir reflux (e.g., cross-sectional area reduction on direct CT venography, MR venography or digital subtraction angiography)
• Informed Consent: Willingness and ability to provide written informed consent prior to study-specific procedures.
• Adherence to Follow-up: Willingness and ability to comply with scheduled follow-up visits and study procedures.

You may not qualify if:

• Primary Pelvic Congestion Syndrome (PCS) only: Patients with significant pelvic venous reflux (e.g., ovarian or internal iliac vein reflux) without demonstrable and significant iliac venous outflow obstruction (i.e., primary PCS without secondary component).
• Pelvic Congestion Syndrome secondary to Nutcracker syndrome.
• Acute Deep Vein Thrombosis (DVT) on the affected side or known uncontrolled hypercoagulable states.
• Contraindications to Anticoagulation: Known severe coagulopathy or absolute contraindications to the required antiplatelet and/or anticoagulant therapy post-stenting.
• Pregnancy.
• Severe Systemic Illness: Patients with severe, uncontrolled systemic diseases (e.g., severe renal failure, uncontrolled heart failure, uncontrolled hypertension, severe liver dysfunction) that would preclude safe participation in an invasive procedure or confound symptom assessment.
• Active Infection: Any active systemic or localized infection, particularly at the access site.
• Malignancy: Known active malignancy, especially pelvic malignancy, which could be the primary cause of pelvic pain or venous compression.
• Other Dominant Causes of Pelvic Pain: Clear evidence of other treatable and dominant causes of chronic pelvic pain (e.g., severe endometriosis, adenomyosis, large uterine fibroids, severe interstitial cystitis, inflammatory bowel disease) that have not been adequately addressed or where these conditions are considered the primary source of pain.
• Known Allergy: Documented severe allergy to contrast media or any components of the embolizing materials that cannot be managed.
• Inability to Consent or Cooperate: Patients with cognitive impairment, psychological instability, or uncooperative behavior that would prevent informed consent or adherence to study procedures and follow-up.

Sponsors & Collaborators

• Mark Magdy Zekry: lead

Related Publications (1)

• 1. Borghi C, Dell'Atti L. Pelvic congestion syndrome: the current state of the literature. Arch Gynecol Obstet. 2016;293(2):291-301. doi:10.1007/s00404-015-3895-7. 2. Bałabuszek K, Toborek M, Pietura R. Comprehensive overview of the venous disorder known as pelvic congestion syndrome. Ann Med. 2022;54(1):22-36. doi:10.1080/07853890.2021.2014556. 3. Ignacio EA, Dua R, Sarin S, et al. Pelvic congestion syndrome: diagnosis and treatment. Semin Intervent Radiol. 2008;25(4):361-368. doi:10.1055/s-0028-1102998. 4. O'Brien MT, Gillespie DL. Diagnosis and treatment of the pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2015;3(1):96-106. doi:10.1016/j.jvsv.2014.05.007. 5. Lakhanpal G, Kennedy R, Lakhanpal S, Sulakvelidze L, Pappas PJ. Pelvic venous insufficiency secondary to iliac vein stenosis and ovarian vein reflux treated with iliac vein stenting alone. J Vasc Surg Venous Lymphat Disord. 2021;9(5):1193-1198. doi:10.1016/j.jvsv.2021.03.006 6. Gavrilov SG, Vasilyev AV, Krasavin GV, Moskalenko YP, Mishakina NY. Endovascular interventions in the treatment of pelvic congestion syndrome caused by May-Thurner syndrome. J Vasc Surg Venous Lymphat Disord. 2020;8(6):1049-1057. doi:10.1016/j.jvsv.2020.02.01 7. Daugherty SF. Nonthrombotic Venous Obstructions Cause Pelvic Congestion Syndrome. J Vasc Surg Venous Lymphat Disord. 2015;3(1):117-118. doi:10.1016/j.jvsv.2014.10.008

  BACKGROUND

MeSH Terms

Interventions

Embolization, Therapeutic

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vascular and endovascular Surgery Resident

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03