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

Not Applicable

Completed

• Conditions: Pelvic Congestion Syndrome
• Interventions: Device: Fibered platinum coils; Device: Vascular plugs

• Registration Number: NCT02796092
• Lead Sponsor: Group of Research in Minimally Invasive Techniques

Brief Summary

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

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).

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-02
• Study Completion: 2016-04
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-10
• Results First Submitted: 2016-07-21
• Results First Submitted QC: 2016-09-02
• Results First Posted: 2016-10-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibered platinum coils	Fibered platinum coils	Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Vascular plugs	Vascular plugs	Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)

Primary Outcome Measures

Name	Time	Method
Change in Pain Scale	12 months	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)

Secondary Outcome Measures

Name	Time	Method
Cost of Treatment	Intraoperative	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.
Procedure Radiation Dose (DAP)	Intraoperative	DAP, dose area product of the intervention, (in mGy\*cm\^2), recorded by fluoroscopy equipment
Total Intervention Duration	Intraoperative	Total time length of the procedure, from puncture to compression (in minutes)
Need for Re-embolization	12 months	Scheduled re-embolization due to incomplete occlusion
Improvement of Urinary Urgency	12 months	Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Satisfaction With the Procedure	12 months	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.
Fluoroscopy Time	Intraoperative	Total fluoroscopy time, recorded by the equipment (in minutes)
Procedure Radiation Dose (AK)	Intraoperative	AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment
Complications	12 months	Toral number of events related to the procedure in the follow-up (1 year)
Improvement of Dyspareunia	12 months	Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Improvement of Dysmenorrhea	12 months	Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Number of Devices Used	intraoperative	Number of coils and number of vascular plugs used in each procedure

Trial Locations

Locations (1)

Lozano Blesa University Hospital; 🇪🇸 Zaragoza, Spain