Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome

Study Overview
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Brief Summary
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This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.

Detailed Description
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This prospective randomized study compares the safety and efficacy of two embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook Medical) and vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).

Official Title
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Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome

Conditions
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Pelvic Congestion Syndrome

Intervention / Treatment
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* Device: Fibered platinum coils
* Device: Vascular plugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Presence of chronic abdominal or pelvic pain for more than 6 months >6 mm pelvic venous caliber measured by transvaginal US Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US Exclusion Criteria: Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma Glomerular filtration rate <60 ml/min History of contrast reaction Patients not able to be followed up for at least one year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibered platinum coils<br>Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) | Device: Fibered platinum coils<br> <br> * Other names: Nester coils;|
| Experimental: Vascular plugs<br>Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) | Device: Vascular plugs<br> <br> * Other names: Amplatzer vascular plugs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Scale | Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9). VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Dyspareunia | Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) | 12 months | 
| Improvement of Urinary Urgency | Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) | 12 months | 
| Improvement of Dysmenorrhea | Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) | 12 months | 
| Satisfaction With the Procedure | Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9). Patients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem. | 12 months | 
| Number of Devices Used | Number of coils and number of vascular plugs used in each procedure | intraoperative | 
| Cost of Treatment | Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay. | Intraoperative | 
| Total Intervention Duration | Total time length of the procedure, from puncture to compression (in minutes) | Intraoperative | 
| Fluoroscopy Time | Total fluoroscopy time, recorded by the equipment (in minutes) | Intraoperative | 
| Procedure Radiation Dose (DAP) | DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment | Intraoperative | 
| Procedure Radiation Dose (AK) | AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment | Intraoperative | 
| Complications | Total number of events during the procedure | intraoperative | 
| Complications | Toral number of events related to the procedure in the follow-up (1 year) | 12 months | 
| Need for Re-embolization | Scheduled re-embolization due to incomplete occlusion | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Congestion Syndrome, Pelvic Venous Insufficiency, Chronic pelvic pain