Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome

NCT06560294 | Recruiting

• 1 other identifier: 36264PR752/7/24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glue Embolization; Pelvic Congestion Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of recurrence of pain

  Post intervention for 3 months

• Pelvic Venous Clinical Severity Score (PVCSS)

  Post intervention for 3 months

Study Arms (2)

Micronized purified flavonoid fraction (Daflon ®)

ACTIVE COMPARATOR

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

Drug: Micronized purified flavonoid fraction (Daflon ®)

Glue embolization

EXPERIMENTAL

Patients will receive transcatheter glue embolization.

Other: Glue embolization

Interventions

Micronized purified flavonoid fraction (Daflon ®) DRUG

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

Micronized purified flavonoid fraction (Daflon ®)

Glue embolization OTHER

Patients will receive transcatheter glue embolization.

Glue embolization

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: Women with pelvic congestion syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged from 30 to 50 years.
• Complaining from pelvic congestion syndrome.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, ElGharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Diosmin

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Mohamed I Eleissawy, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Vascular and Endovascular Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 19, 2024
• Study Start: August 17, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)