Pelvic Congestive Syndrome, Pelvic Varices, Venous Disease
Conditions
Keywords
pelvic congestion syndrome, sclerosis, coil embolization
Brief 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.
Interventions
DEVICEMedtronic® Concerto® detachable coil system
coil embolization of the reflux pathways
PROCEDUREsclerosis
Pelvic varices sclerosis with polidocanol foam
Best chronic medial treatment
DRUGIbuprofen 400 mg
NSAID treatment
Sponsors
University of the Republic, Uruguay
Centro Cardiovascular Universitario
Centro Hospitalario Pereyra Rossell
Hospital de Clínicas Dr. Manuel Quintela
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Blind randomized clinical trial designed to compare the efficacy and safety of endovascular treatment of Pelvic congestion syndrome.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| McGill Pain Questionnaire | 30 days | subjective pain experience assessment |
| visual analogue scale (VAS) | 30 days | Pain assessment 1-10 from no pain to severe |
| Lattinen index | 30 days | chronic pain assessment 2-22 from low to high |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| varicose and reflux persistance by transvaginal duplex scan | 3 months | transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux |
| varicose persistance assesment by tomography | 3 months | angiotomography: Varicose and conadic Patency |
| Female sexual function index | 30 days | questionnaire that assesses different domains of sexual function. 0-48 from no sexual distress to high level of sexual distress |
| varicose and reflux persistance by transabdominal duplex scan | 30 days | transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux |
Other
| Measure | Time frame | Description |
|---|---|---|
| Deep venous thrombosis by duplex ultrasound | 30 days | Deep venous thrombosis of the iliac or femoral axis will be reported |
Contacts
Primary ContactSebastian Sarutte, VS
Backup ContactMauricio Volpi, VS
Outcome results
None listed