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 Type
INTERVENTIONAL
Allocation
coil embolization of the reflux pathways
Pelvic varices sclerosis with polidocanol foam
Best chronic medial treatment
visual analogue scale (VAS)
Pain assessment 1-10 from no pain to severe
Time frame: 30 days
visual analogue scale (VAS)
Pain assessment 1-10 from no pain to severe
Time frame: 3 months
Lattinen index
chronic pain assessment 2-22 from low to high
Time frame: 30 days
Lattinen index
chronic pain assessment 2-22 from low to high
Time frame: 3 months
McGill Pain Questionnaire
subjective pain experience assessment
Time frame: 30 days
McGill Pain Questionnaire
subjective pain experience assessment
Time frame: 3 months
Female sexual function index
questionnaire that assesses different domains of sexual function. 0-48 from no sexual distress to high level of sexual distress
Time frame: 30 days
Female sexual function index
questionnaire that assesses different domains of sexual function. . 0-48 from no sexual distress to high level of sexual distress
Time frame: 3 months
varicose and reflux persistance by transabdominal duplex scan
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RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
NSAID treatment
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
Time frame: 30 days
varicose and reflux persistance by transabdominal duplex scan
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
Time frame: 3 months
varicose and reflux persistance by transvaginal duplex scan
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
Time frame: 3 months
varicose persistance assesment by tomography
angiotomography: Varicose and conadic Patency
Time frame: 3 months