Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome

Glue Embolization Versus Conservative Treatment for Pelvic Congestion Syndrome: A Randomized Trial

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

Study Overview

• Status: Recruiting
• Conditions: Pelvic Congestion Syndrome; Glue Embolization
• Intervention / Treatment: Drug: Micronized purified flavonoid fraction (Daflon ®); Other: Glue embolization

Detailed Description

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
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed I Eleissawy, MD; Phone Number: 00201110036328; Email: mohamed.elesawy@med.tanta.edu.eg

Study Locations

• Egypt
  • ElGharbia
    • Tanta, ElGharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Mohamed I Eleissawy, MD; Phone Number: 00201110036328; Email: mohamed.elesawy@med.tanta.edu.eg
      • Principal Investigator: Hossam M Khalil, MD
      • Principal Investigator: Mai N Ageez, MD
      • Principal Investigator: Mohamed E Eleiwa, MD
      • Principal Investigator: Abdelrahman A Nagy, MD

Participation Criteria

Eligibility Criteria

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

Description

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.

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: Micronized purified flavonoid fraction (Daflon ®); Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months.	Drug: Micronized purified flavonoid fraction (Daflon ®); Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months.
Experimental: Glue embolization; Patients will receive transcatheter glue embolization.	Other: Glue embolization; Patients will receive transcatheter glue embolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Post intervention for 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post intervention for 3 months
Incidence of recurrence of pain	Incidence of recurrence of pain will be recorded.	Post intervention for 3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 36264PR752/7/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No