Pelvic Congestion Syndrome
Conditions
Brief summary
Pelvic congestion syndrome (PCS) is a common cause of chronic pelvic pain in women and is associated with pelvic venous insufficiency. This prospective interventional study aims to evaluate the safety and clinical effectiveness of endovascular embolization in relieving symptoms and improving quality of life in women diagnosed with PCS
Detailed description
Pelvic congestion syndrome is characterized by chronic pelvic pain resulting from pelvic venous reflux and varicosities. Endovascular embolization has emerged as a minimally invasive treatment with promising clinical outcomes. This prospective interventional study will evaluate the efficacy and safety of endovascular embolization in female patients with clinically suspected and imaging-confirmed PCS. Patients will undergo clinical assessment, imaging evaluation, and endovascular treatment according to standard institutional protocols. Clinical outcomes will be assessed using pain scores and symptom improvement during follow-up, while procedural success, technical outcomes, and complications will also be recorded
Interventions
PROCEDUREEndovascular embolization
Transcatheter embolization of incompetent ovarian and/or pelvic veins using standard embolic materials according to institutional practice to treat pelvic congestion syndrome.
Sponsors
Sohag University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Transcatheter embolization of incompetent ovarian and/or pelvic veins using standard embolic agents according to institutional protocol.
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 years or older. * Chronic pelvic pain for more than 6 months. * Clinical suspicion of pelvic congestion syndrome. * Imaging findings consistent with pelvic congestion syndrome on Doppler ultrasound, CT venography, MR venography, or catheter venography. * Patients willing to undergo endovascular embolization. * Written informed consent obtained
Exclusion criteria
* Pregnancy. * Active pelvic inflammatory disease. * Known pelvic malignancy. * Chronic pelvic pain due to other identifiable causes (e.g., endometriosis, large uterine fibroids). * Contraindication to iodinated contrast media. * Severe renal impairment. * Uncorrectable coagulation disorders. * Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in pelvic pain after endovascular embolization | 6 months | Change in pelvic pain measured using the Visual Analog Scale (VAS, 0-10), comparing baseline with 6-month follow-up. Unit of Measure: VAS score (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of embolization | during the procedure | Percentage of patients with successful catheterization and complete embolization of all incompetent ovarian and/or pelvic veins during the procedure. Unit: Percentage of participants (%) |
| Change in quality of life | 6 months | Change in quality of life assessed using the Pelvic Venous Clinical Severity Score (PVCSS) or another predefined questionnaire at baseline and 6 months. Unit: Score |
| Procedure-related complications | up to 30 days after the procedure | Assessment of major and minor complications according to the Society of Interventional Radiology (SIR) classification. |
| Quality of life improvement | 6 months | Improvement in patient's quality of life following embolization |
Countries
Egypt
Contacts
CONTACTAhmed Nageh Younis, M.B.B.Ch.
PRINCIPAL_INVESTIGATORMohammed Zaki Ali, Professor of Radiology
Sohag University
Outcome results
None listed