Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome (ENDPCS)

Hospital de Clínicas Dr. Manuel Quintela

Status and phase: Unknown; Phase 4

Conditions: Pelvic Varices; Venous Disease; Pelvic Congestive Syndrome

Treatments: Drug: Ibuprofen 400 mg; Device: Medtronic® Concerto® detachable coil system; Drug: Diosmin / Hesperidin; Procedure: sclerosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04358497

TR001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Interventional treatment plus best chronic medical treatment

Experimental group

Description:

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

Treatment:

Procedure: sclerosis

Drug: Diosmin / Hesperidin

Device: Medtronic® Concerto® detachable coil system

Drug: Ibuprofen 400 mg

Best chronic medical treatment alone

Active Comparator group

Description:

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

Treatment:

Drug: Diosmin / Hesperidin

Drug: Ibuprofen 400 mg