NCT04358497

Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hospital de Clínicas Dr. Manuel Quintela · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Pelvic Congestive Syndrome
• Pelvic Varices
• Venous Disease

Interventions

Type	Name	Description
DEVICE	Medtronic® Concerto® detachable coil system	coil embolization of the reflux pathways
PROCEDURE	sclerosis	Pelvic varices sclerosis with polidocanol foam
DRUG	Diosmin / Hesperidin	Best chronic medial treatment
DRUG	Ibuprofen 400 mg	NSAID treatment

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-07-31
• Completion: 2022-10-01
• First posted: 2020-04-24
• Last updated: 2020-04-24

Regulatory

• FDA-regulated drug study
• FDA-regulated device study