Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Micronized purified flavonoid fraction (Daflon ®), Glue embolization.
- Who it may be relevant to
- Registry conditions: Glue Embolization, Pelvic Congestion Syndrome. Basic parameters: 30 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Glue Embolization Versus Conservative Treatment for Pelvic Congestion Syndrome: A Randomized Trial
Overview
The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.
Detailed 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.
Interventions
- Drug Micronized purified flavonoid fraction (Daflon ®)
Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months. - Other Glue embolization
Patients will receive transcatheter glue embolization.
Primary outcome measures
- Degree of pain [Time frame: Post intervention for 3 months]
Secondary outcome measures (2)
- Incidence of recurrence of pain [Time frame: Post intervention for 3 months]
- Pelvic Venous Clinical Severity Score (PVCSS) [Time frame: Post intervention for 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT06560294 · 36264PR752/7/24