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The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micronized purified flavonoid fraction (Daflon ®) | Active Comparator | Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months. |
|
| Glue embolization | Experimental | Patients will receive transcatheter glue embolization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronized purified flavonoid fraction (Daflon ®) | Drug | Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of recurrence of pain | Incidence of recurrence of pain will be recorded. | Post intervention for 3 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women with pelvic congestion syndrome
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed I Eleissawy, MD | Contact | 00201110036328 | mohamed.elesawy@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | ElGharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D004145 | Diosmin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Glue embolization | Other | Patients will receive transcatheter glue embolization. |
|
| Post intervention for 3 months |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |