Embolization Strategies for Pelvic Venous Disorders: Foam + Glue vs Foam + Coils (foam and coil)

Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders:

Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial

Study Overview

• Status: Enrolling by invitation
• Conditions: Pelvic Congestive Syndrome
• Intervention / Treatment: Other: Foam + N-butyl Cyanoacrylate; Other: Combined Foam Sclerotherapy and Detachable Coil Embolization

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafrelshaykh Governorate
    • Kafr ash Shaykh, Kafrelshaykh Governorate, Egypt, 33511
      • Kafr El Shaykh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Female patients aged 18 to 50 years
• Clinically suspected pelvic venous disorder (PVD), presenting with chronic pelvic pain ≥ 6 months
• Pelvic pain intensity ≥ 4 on a 10-point Visual Analogue Scale (VAS) at baseline
• No evidence of significant venous obstruction or internal iliac insufficiency
• Willingness to participate, provide written informed consent, and comply with study visits and procedures exclusion criteria
• Pregnancy or planning to conceive within the next 12 months
• Significant Nutcracker syndrome diagnosed by duplex / CTV / MRV
• Significant May-Thurner syndrome diagnosed by duplex / CTV / MRV
• Non-ovarian sources of reflux requiring intervention, including internal iliac vein insufficiency; During venography all patients will undergo selective pelvic venography prior embolization to exclude patients who have combined gonadal and internal iliac vein reflux)
• History of previous pelvic vein embolization or surgical ligation

• Coagulopathy, defined as:

  • INR > 1.5
  • Platelet count < 50 × 10⁹/L

• Severe comorbidities, including:

  • Active pelvic infection (e.g., pelvic inflammatory disease)
  • End-stage renal disease (eGFR < 30 mL/min/1.73 m²)
  • Decompensated heart failure (NYHA class III-IV)
  • Active malignancy requiring treatment

Known allergy or hypersensitivity to:

• Iodinated contrast media
• Polidocanol (Aethoxysklerol®)
• N-butyl cyanoacrylate (e.g., Gluebran® 2)
• Nickel, platinum, or stainless steel (components of embolization coils) . Presence of non-venous pelvic pathology requiring immediate management

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Embolization using polidocanol foam followed by N-butyl cyanoacrylate; . After selective catheterization of the ovarian vein and reflux confirmation, Sclerosant foam will be prepared using 3% polidocanol (Aethoxysklerol®, Kreussler Pharma), mixed with room air in a 1:4 ratio (1 mL polidocanol to 4 mL air) using the Tessari double-syringe technique, creating a dense and stable foam. The foam will be injected slowly into the reservoir of the refluxing segment of the ovarian vein under fluoroscopic guidance to induce endothelial irritation and reduce venous flow. A total of 5-10 mL of 3% polidocanol foam will be injected per vein, adjusted based on vein diameter and reflux length. Next, N-butyl cyanoacrylate (Gluebran®️ 2) will be mixed with Lipiodol in a 1:2 to 1:3 ratio, depending on vein size and flow rate. Approximately 1-2 mL of the glue mixture will be injected per vein using a coaxial microcatheter system from distal to proximal segments. Occlusion will be confirmed by post-embolization venography."	Other: Foam + N-butyl Cyanoacrylate; 3% polidocanol (Aethoxysklerol®, Kreussler Pharma), mixed with room air in a 1:4 ratio (1 mL polidocanol to 4 mL air) using the Tessari double-syringe technique, creating a dense and stable foam.
Active Comparator: Combined Foam Sclerotherapy and Detachable Coil Embolization; Patients in this group will undergo embolization using sclerosant foam followed by detachable platinum coils. Vascular access and catheterization technique will mirror Group A. After injecting polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic) - will be deployed to achieve permanent mechanical occlusion. Coil selection (diameter and length) will be based on intra-procedural vein sizing. Final occlusion will be confirmed via completion venography.	Other: Combined Foam Sclerotherapy and Detachable Coil Embolization; polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the clinical efficacy of ovarian vein embolization using combined foam plus N-butyl cyanoacrylate (Gluebran®️) versus combined foam plus detachable coils	2. Symptom severity reduction, assessed by the Pelvic Venous Clinical Severity Score (PVCSS) at baseline, 3, 6, 12, and 18 months.	18 months

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Actual): August 25, 2025
• Study Completion (Estimated): December 25, 2025

Study Registration Dates

• First Submitted: October 12, 2025
• First Submitted That Met QC Criteria: October 25, 2025
• First Posted (Estimated): October 28, 2025

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 25, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Acids, Acyclic; Carboxylic Acids; Cyanoacrylates; Acrylates; Nitriles; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Tissue Adhesives; Enbucrilate
• Other Study ID Numbers: glue vs coil for ovarian ttt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes