Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome

Tanta University40 enrolled

Overview

The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.

Pelvic congestion syndrome (PCS) is a common cause of chronic lower abdominal/pelvic pain, estimated to affect about 40 % of women, predominantly between the ages of 30 and 45.The treatment of PCS depends mainly on the severity of the pain. Non-steroid anti-inflammatory drugs are often used, and contraceptives have a role in cases of pain associated predominantly with menstruation. Traditionally, conservative approaches, such as pharmacotherapy with venoactive drugs like micronized purified flavonoid fraction (Daflon), have been utilized to address the symptoms of PCS. Daflon has been used to treat venous insufficiency and has demonstrated efficacy in reducing symptoms and improving the quality of life in patients with PCS. Its mechanism of action includes improving venous tone, reducing venous stasis, and exerting anti-inflammatory effects. Endovascular treatment of PCS is challenging and requires occlusion of incompetent pelvic veins.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glue Embolization Pelvic Congestion Syndrome

Interventions

Micronized purified flavonoid fraction (Daflon ®)DRUG

Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months.

Glue embolizationOTHER

Patients will receive transcatheter glue embolization.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged from 30 to 50 years. * Complaining from pelvic congestion syndrome. Exclusion Criteria: * Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers. * Patients who are treated with opiates to reduce pelvic pain in the period before the study. * Patient with history of contrast allergy * Patient with renal impairment * Patient has alternative gynecological cause of chronic pelvic pain as pelvic inflammatory disease (PID), endometriosis, fibroid, adenomyosis, ovarian cyst * Patient underwent any previous intervention for pelvic congestion syndrome as laparoscopy or surgery.

Locations (1)

Tanta University

Tanta, ElGharbia, Egypt

RECRUITING

Outcomes

Primary Outcomes

Degree of pain

Degree of pain will be assessed using a Visual Analog Scale (VAS). The VAS is a self-reported scale consisting of a horizontal or vertical line, usually 10 cm long. An introductory question asks the patient to mark a point on the line that best refers to his or her pain. Patients will be encouraged to assess the intensity of subjective manifestation of each symptom by scoring from 0 (no symptom) to 10 (the most extreme manifestation possible).

Time frame: Post intervention for 3 months

Secondary Outcomes

Incidence of recurrence of pain

Incidence of recurrence of pain will be recorded.

Time frame: Post intervention for 3 months

Pelvic Venous Clinical Severity Score (PVCSS)

Assessment of treatment outcomes will be standardized using the disease-specific Pelvic Venous Clinical Severity Score (PVCSS) for female patients with pelvic congestion syndrome. The PVCSS takes into account 10 major symptoms and signs of the disease, each of which is scored from 0 (no symptom) to 3 (maximum severity) for a maximum score of 30, which indicates an extremely severe degree of disease.

Time frame: Post intervention for 3 months

Central Contacts

Mohamed I Eleissawy, MD

CONTACT

00201110036328 mohamed.elesawy@med.tanta.edu.eg

Data from ClinicalTrials.gov

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