Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome

Tanta University

Status: Enrolling

Conditions: Glue Embolization; Pelvic Congestion Syndrome

Treatments: Other: Glue embolization; Drug: Micronized purified flavonoid fraction (Daflon ®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06560294

36264PR752/7/24

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Micronized purified flavonoid fraction (Daflon ®)

Active Comparator group

Description:

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

Treatment:

Drug: Micronized purified flavonoid fraction (Daflon ®)

Glue embolization

Experimental group

Description:

Patients will receive transcatheter glue embolization.

Treatment:

Other: Glue embolization