Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
- Conditions
- Pelvic VaricesPelvic Congestive SyndromeVenous Disease
- Interventions
- Device: Medtronic® Concerto® detachable coil systemProcedure: sclerosis
- Registration Number
- NCT04358497
- Lead Sponsor
- Hospital de Clínicas Dr. Manuel Quintela
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional treatment plus best chronic medical treatment Medtronic® Concerto® detachable coil system Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months Interventional treatment plus best chronic medical treatment sclerosis Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months Interventional treatment plus best chronic medical treatment Diosmin / Hesperidin Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months Interventional treatment plus best chronic medical treatment Ibuprofen 400 mg 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 Diosmin / Hesperidin Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months Best chronic medical treatment alone Ibuprofen 400 mg Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
- Primary Outcome Measures
Name Time Method visual analogue scale (VAS) 3 months Pain assessment 1-10 from no pain to severe
Lattinen index 3 months chronic pain assessment 2-22 from low to high
McGill Pain Questionnaire 3 months subjective pain experience assessment
- Secondary Outcome Measures
Name Time Method Female sexual function index 3 months 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 3 months transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
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