Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of the Republic, Uruguay | OTHER |
| Centro Cardiovascular Universitario | UNKNOWN |
| Centro Hospitalario Pereyra Rossell | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic® Concerto® detachable coil system | Device | coil embolization of the reflux pathways |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Deep venous thrombosis by duplex ultrasound | Deep venous thrombosis of the iliac or femoral axis will be reported | 30 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Sarutte, VS | Contact | +59899533449 | ssarutte1@hotmail.com | |
| Mauricio Volpi, VS | Contact | +59899605556 | mavolpi@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Sebastian Sarutte, VS | Centro Cardiovascular Universitario | Principal Investigator |
Not provided
De-identified data base for all variables will be available for researchers
From April 2022 to april 2024
Data will be shared on request, after signing a discretion agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D012598 | Sclerosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004145 | Diosmin |
| D006569 | Hesperidin |
| D007052 | Ibuprofen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
Not provided
Not provided
Blind randomized clinical trial designed to compare the efficacy and safety of endovascular treatment of Pelvic congestion syndrome.
Not provided
Not provided
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.
| sclerosis | Procedure | Pelvic varices sclerosis with polidocanol foam |
|
|
| Diosmin / Hesperidin | Drug | Best chronic medial treatment |
|
|
| Ibuprofen 400 mg | Drug | NSAID treatment |
|
|
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 |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D044950 | Flavanones |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |