Clinical trial NCT04358497: Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
Official title: Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pelvic Congestive Syndrome
Pelvic Varices
Venous Disease
Keywords: pelvic congestion syndrome
sclerosis
coil embolization
Lead sponsor: Hospital de Clínicas Dr. Manuel Quintela
Sponsor class: OTHER
Collaborators: name: University of the Republic, Uruguay
name: Centro Cardiovascular Universitario
name: Centro Hospitalario Pereyra Rossell
First posted: 2020-04-24
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blind randomized clinical trial designed to compare the efficacy and safety of endovascular treatment of Pelvic congestion syndrome.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: visual analogue scale (VAS)
timeFrame: 30 days
measure: visual analogue scale (VAS)
timeFrame: 3 months
measure: Lattinen index
timeFrame: 30 days
measure: Lattinen index
timeFrame: 3 months
measure: McGill Pain Questionnaire
timeFrame: 30 days
measure: McGill Pain Questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Female sexual function index
timeFrame: 30 days
measure: Female sexual function index
timeFrame: 3 months
measure: varicose and reflux persistance by transabdominal duplex scan
timeFrame: 30 days
measure: varicose and reflux persistance by transabdominal duplex scan
timeFrame: 3 months
measure: varicose and reflux persistance by transvaginal duplex scan
timeFrame: 3 months
measure: varicose persistance assesment by tomography
timeFrame: 3 months
Other outcomes:
measure: Deep venous thrombosis by duplex ultrasound
timeFrame: 30 days
Locations:
Study officials:
affiliation: Centro Cardiovascular Universitario
name: Sebastian Sarutte, VS
role: PRINCIPAL_INVESTIGATOR
References: