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

Group of Research in Minimally Invasive Techniques100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Pelvic Congestion Syndrome

Interventions

Fibered platinum coilsDEVICE

Vascular plugsDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Lozano Blesa University Hospital

Zaragoza, Zaragoza, Spain

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Secondary Outcomes

Improvement of Dyspareunia

Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 12 months

Number of Devices Used

Number of coils and number of vascular plugs used in each procedure

Time frame: intraoperative

Cost of Treatment

Data from ClinicalTrials.gov

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