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

Group of Research in Minimally Invasive Techniques1 site in 1 country100 target enrollmentFebruary 2014

ConditionsPelvic Congestion Syndrome

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pelvic Congestion Syndrome
Sponsor: Group of Research in Minimally Invasive Techniques
Enrollment: 100
Locations: 1
Primary Endpoint: Change in Pain Scale
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Group of Research in Minimally Invasive Techniques

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Pain Scale

Time Frame: 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)