Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome

Conditions
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Pelvic Congestive Syndrome, Pelvic Varices, Venous Disease

Intervention / Treatment
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* Device: Medtronic® Concerto® detachable coil system
* Procedure: sclerosis
* Drug: Diosmin / Hesperidin
* Drug: Ibuprofen 400 mg


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Blind randomized clinical trial designed to compare the efficacy and safety of endovascular treatment of Pelvic congestion syndrome.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional treatment plus best chronic medical treatment<br>Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months | Device: Medtronic® Concerto® detachable coil system<br>* coil embolization of the reflux pathways<br>* Other names: concerto detachable coil system;Procedure: sclerosis<br>* Pelvic varices sclerosis with polidocanol foam<br>* Other names: Foam sclerosis with polidocanol 2%;Drug: Diosmin / Hesperidin<br>* Best chronic medial treatment<br>* Other names: daflon;Drug: Ibuprofen 400 mg<br>* NSAID treatment<br>* Other names: Nsaid;|
| Active Comparator: Best chronic medical treatment alone<br>Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months | Drug: Diosmin / Hesperidin<br>* Best chronic medial treatment<br>* Other names: daflon;Drug: Ibuprofen 400 mg<br>* NSAID treatment<br>* Other names: Nsaid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale (VAS) | Pain assessment 1-10 from no pain to severe | 30 days | 
| visual analogue scale (VAS) | Pain assessment 1-10 from no pain to severe | 3 months | 
| Lattinen index | chronic pain assessment 2-22 from low to high | 30 days | 
| Lattinen index | chronic pain assessment 2-22 from low to high | 3 months | 
| McGill Pain Questionnaire | subjective pain experience assessment | 30 days | 
| McGill Pain Questionnaire | subjective pain experience assessment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female sexual function index | questionnaire that assesses different domains of sexual function. 0-48 from no sexual distress to high level of sexual distress | 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 | 3 months | 
| varicose and reflux persistance by transabdominal duplex scan | transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux | 30 days | 
| varicose and reflux persistance by transabdominal duplex scan | transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux | 3 months | 
| varicose and reflux persistance by transvaginal duplex scan | transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux | 3 months | 
| varicose persistance assesment by tomography | angiotomography: Varicose and conadic Patency | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sclerosis, pelvic congestion syndrome, coil embolization