Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome

Last updated: August 17, 2024
Sponsor: Tanta University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Genitourinary Prolapse

Treatment

Glue embolization

Micronized purified flavonoid fraction (Daflon ®)

Clinical Study ID

NCT06560294
36264PR752/7/24
  • Ages 30-50
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged from 30 to 50 years.

  • Complaining from pelvic congestion syndrome.

Exclusion

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 thestudy.

  • Patient with history of contrast allergy

  • Patient with renal impairment

  • Patient has alternative gynecological cause of chronic pelvic pain as pelvicinflammatory disease (PID), endometriosis, fibroid, adenomyosis, ovarian cyst

  • Patient underwent any previous intervention for pelvic congestion syndrome aslaparoscopy or surgery.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Glue embolization
Phase:
Study Start date:
August 17, 2024
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Tanta University

    Tanta, ElGharbia 31527
    Egypt

    Active - Recruiting

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