Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-10-01

Brief Summary

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Compare the efficacy and safety of endovascular treatment with sandwich technique (controlled release coils and 2% polidocanol foam) associated with diosmin-hisperidine and ibuprofen medical treatment and only the best chronic medical treatment available diosmin-hisperidine and ibuprofen for 3 months, in women of active gynecological age carrying pelvic congestion syndrome in public assistance in Montevideo, Uruguay.

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Detailed Description

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Pelvic congestion syndrome (PCS) is a recognized and frequent cause of Chronic Pelvic Pain (10% to 30%). It is defined as the presence of chronic symptoms, which may include pelvic pain, perineal heaviness, urinary urgency and postcoital pain, caused by reflux and / or obstruction of the gonadic and / or pelvic veins, and that may be associated with vulvar, perineal and lower limbs varicose veins.

There is no standard approach to managing PCS. According to expert recommendations, therapies should be individualized according to the patient's symptoms and needs.

Medical treatment options include progestagens, danazol, combined oral hormonal contraceptives, phlebotonics such as hisperidine-added diosmin, non-steroidal anti-inflammatory drugs and gonadotropin-releasing hormone (GnRH) agonists

Currently, the only accepted chronic medical treatment is the association of non-steroidal and phlebotonic anti-inflammatories, but they have shown a poor symptomatic benefit in reducing pain.

Surgical treatment has evolved over time mainly in the hands of laparoscopic techniques, currently the endovascular option is the most widely accepted for presenting excellent long-term results with abolition of pain in up to 90% at 2 years.

HYPOTHESIS

Endovascular treatment of pelvic congestion syndrome is better in terms of pain control and quality of life compared to drug treatment.

General objective

Compare the efficacy and safety of endovascular treatment with sandwich technique (controlled release coils and 2% polidocanol foam) associated with diosmin-hisperidine and ibuprofen medical treatment and only the best chronic medical treatment available diosmin-hisperidine and ibuprofen for 3 months, in women of active gynecological age carrying pelvic congestion syndrome in public assistance in Montevideo, Uruguay.

Specific objectives

• Compare pain in patients undergoing endovascular treatment with the best

medical treatment.

* Evaluate the persistence of pelvic varices in patients undergoing endovascular treatment of SCP.
* Compare the Female Sexual Satisfaction Index in both groups.

Conditions

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Pelvic Congestive Syndrome Pelvic Varices Venous Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blind randomized clinical trial designed to compare the efficacy and safety of endovascular treatment of Pelvic congestion syndrome.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Phlebography will be performed to both groups. On the experimental group, the treatment of the pelvic congestion will be performed, while the procedure will be stopped on the control group. Neither the patient or the reference gynecologist will be informed if the treatment took place.

Study Groups

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Interventional treatment plus best chronic medical treatment

Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months

Group Type EXPERIMENTAL

Medtronic® Concerto® detachable coil system

Intervention Type DEVICE

coil embolization of the reflux pathways

sclerosis

Intervention Type PROCEDURE

Pelvic varices sclerosis with polidocanol foam

Diosmin / Hesperidin

Intervention Type DRUG

Best chronic medial treatment

Ibuprofen 400 mg

Intervention Type DRUG

NSAID treatment

Best chronic medical treatment alone

Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months

Group Type ACTIVE_COMPARATOR

Diosmin / Hesperidin

Intervention Type DRUG

Best chronic medial treatment

Ibuprofen 400 mg

Intervention Type DRUG

NSAID treatment

Interventions

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Medtronic® Concerto® detachable coil system

coil embolization of the reflux pathways

Intervention Type DEVICE

sclerosis

Pelvic varices sclerosis with polidocanol foam

Intervention Type PROCEDURE

Diosmin / Hesperidin

Best chronic medial treatment

Intervention Type DRUG

Ibuprofen 400 mg

NSAID treatment

Intervention Type DRUG

Other Intervention Names

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concerto detachable coil system Foam sclerosis with polidocanol 2% daflon Nsaid

Eligibility Criteria

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Inclusion Criteria

* Active gynecological age
* Chronic pelvic pain diagnosed by gynecologist of at least 6 months of evolution.
* Transvaginal duplex ultrasound: presence of periuterine varicose veins defined by veins larger than 5mm in diameter with reflux greater than 0.5 seconds on Valsava maneuvers.

Exclusion Criteria

* Presence of other causes of chronic pelvic pain: endometriosis, pelvic inflammatory disease, postoperative adhesions, uterine myoma, adenomyosis, ovarian tumors, polycystic ovary.
* Fibromyalgia
* BMI greater than 35
* Chronic kidney disease
* thrombophilia
* Alterationof coagulation.
* Allergy to iodinated contrast medium.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No