Pelvic Congestive Syndrome
Conditions
Brief summary
Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial
Interventions
OTHERFoam + 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.
OTHERCombined Foam Sclerotherapy and Detachable Coil Embolization
polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic)
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| compare the clinical efficacy of ovarian vein embolization using combined foam plus N-butyl cyanoacrylate (Gluebran®️) versus combined foam plus detachable coils | 18 months | 2\. Symptom severity reduction, assessed by the Pelvic Venous Clinical Severity Score (PVCSS) at baseline, 3, 6, 12, and 18 months. |
Countries
Egypt
Outcome results
None listed