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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Congestion Syndrome
• Intervention / Treatment: Device: Fibered platinum coils; Device: 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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50003
    • Lozano Blesa University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Group of Research in Minimally Invasive Techniques
• Investigators: Principal Investigator: Miguel A De Gregorio, MD, PhD, Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Chronic pelvic pain; Pelvic Congestion Syndrome; Pelvic Venous Insufficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: GTM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No