Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome

Venous Disease Clinical Trial

— ENDPCS  

Official title:

Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04358497
• Other study ID #: TR001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: April 2020
• Source: Hospital de Clínicas Dr. Manuel Quintela
• Contact: Sebastian Sarutte, VS
• Phone: +59899533449
• Email: ssarutte1[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 1, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Congestive Syndrome
• Pelvic Varices
• Syndrome
• Venous Disease

Intervention

Device:
• Medtronic® Concerto® detachable coil system
coil embolization of the reflux pathways

Procedure:
• sclerosis
Pelvic varices sclerosis with polidocanol foam

Drug:
• Diosmin / Hesperidin
Best chronic medial treatment
• Ibuprofen 400 mg
NSAID treatment

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Hospital de Clínicas Dr. Manuel Quintela	Centro Cardiovascular Universitario, Centro Hospitalario Pereyra Rossell, University of the Republic, Uruguay

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Deep venous thrombosis by duplex ultrasound	Deep venous thrombosis of the iliac or femoral axis will be reported	30 days
Primary	visual analogue scale (VAS)	Pain assessment 1-10 from no pain to severe	30 days
Primary	visual analogue scale (VAS)	Pain assessment 1-10 from no pain to severe	3 months
Primary	Lattinen index	chronic pain assessment 2-22 from low to high	30 days
Primary	Lattinen index	chronic pain assessment 2-22 from low to high	3 months
Primary	McGill Pain Questionnaire	subjective pain experience assessment	30 days
Primary	McGill Pain Questionnaire	subjective pain experience assessment	3 months
Secondary	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
Secondary	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
Secondary	varicose and reflux persistance by transabdominal duplex scan	transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux	30 days
Secondary	varicose and reflux persistance by transabdominal duplex scan	transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux	3 months
Secondary	varicose and reflux persistance by transvaginal duplex scan	transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux	3 months
Secondary	varicose persistance assesment by tomography	angiotomography: Varicose and conadic Patency	3 months