Trial | NCT04358497  Report issue

Official Title

Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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.
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.
Study Started
Oct 01
2020
Anticipated
Primary Completion
Jul 31
2022
Anticipated
Study Completion
Oct 01
2022
Anticipated
Last Update
Apr 24
2020

Device Medtronic® Concerto® detachable coil system

coil embolization of the reflux pathways

  • Other names: concerto detachable coil system

Procedure sclerosis

Pelvic varices sclerosis with polidocanol foam

  • Other names: Foam sclerosis with polidocanol 2%

Drug Diosmin / Hesperidin [diosmetine, hesperidin]

Best chronic medial treatment

  • Other names: daflon

Drug Ibuprofen 400 mg

NSAID treatment

  • Other names: Nsaid

Interventional treatment plus best chronic medical treatment Experimental

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

Best chronic medical treatment alone Active Comparator

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

Criteria 

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.
No Results Posted