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NCT Number: NCT06560294

Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome

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

Recruiting

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Key information

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, ElGharbia, 31527, Egypt

Location status: Recruiting

Location contact

Abdelrahman A Nagy, MD

PRINCIPAL_INVESTIGATOR

Hossam M Khalil, MD

PRINCIPAL_INVESTIGATOR

Mai N Ageez, MD

PRINCIPAL_INVESTIGATOR

Mohamed E Eleiwa, MD

PRINCIPAL_INVESTIGATOR

Mohamed I Eleissawy, MD

CONTACT

[email protected]

00201110036328

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micronized purified flavonoid fraction (Daflon ®)

Drug

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

Glue embolization

Other

Patients will receive transcatheter glue embolization.

Primary outcomes

  1. Degree of pain

    Time frame: Post intervention for 3 months

    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).

Secondary outcomes

  1. Incidence of recurrence of pain

    Time frame: Post intervention for 3 months

    Incidence of recurrence of pain will be recorded.

  2. Pelvic Venous Clinical Severity Score (PVCSS)

    Time frame: Post intervention for 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed I Eleissawy, MD

CONTACT

[email protected]

00201110036328

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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