Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome (ENDPCS)

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.

Study Overview

• Status: Unknown
• Conditions: Venous Disease; Pelvic Congestive Syndrome; Pelvic Varices
• Intervention / Treatment: Device: Medtronic® Concerto® detachable coil system; Procedure: sclerosis; Drug: Diosmin / Hesperidin; Drug: Ibuprofen 400 mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sebastian Sarutte, VS; Phone Number: +59899533449; Email: ssarutte1@hotmail.com
• Study Contact Backup: Name: Mauricio Volpi, VS; Phone Number: +59899605556; Email: mavolpi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional treatment plus best chronic medical treatment; 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; coil embolization of the reflux pathways; Other Names: concerto detachable coil system; Procedure: sclerosis; Pelvic varices sclerosis with polidocanol foam; Other Names: Foam sclerosis with polidocanol 2%; Drug: Diosmin / Hesperidin; Best chronic medial treatment; Other Names: daflon; Drug: Ibuprofen 400 mg; NSAID treatment; Other Names: Nsaid
Active Comparator: Best chronic medical treatment alone; Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months	Drug: Diosmin / Hesperidin; Best chronic medial treatment; Other Names: daflon; Drug: Ibuprofen 400 mg; NSAID treatment; Other Names: Nsaid

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deep venous thrombosis by duplex ultrasound	Deep venous thrombosis of the iliac or femoral axis will be reported	30 days

Collaborators and Investigators

• Sponsor: Hospital de Clínicas Dr. Manuel Quintela
• Collaborators: University of the Republic, Uruguay; Centro Cardiovascular Universitario; Centro Hospitalario Pereyra Rossell
• Investigators: Principal Investigator: Sebastian Sarutte, VS, Centro Cardiovascular Universitario

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: coil embolization; sclerosis; pelvic congestion syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Pharmaceutical Solutions; Sclerosing Solutions; Ibuprofen; Polidocanol
• Other Study ID Numbers: TR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified data base for all variables will be available for researchers
• IPD Sharing Time Frame: From April 2022 to april 2024
• IPD Sharing Access Criteria: Data will be shared on request, after signing a discretion agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes