Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome

NCT04358497 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: TR001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Congestive Syndrome; Pelvic Varices; Venous Disease

Keywords

pelvic congestion syndrome; sclerosis; coil embolization

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Female sexual function index

  30 days

• Female sexual function index

  3 months

• varicose and reflux persistance by transabdominal duplex scan

  30 days

• varicose and reflux persistance by transabdominal duplex scan

  3 months

• varicose and reflux persistance by transvaginal duplex scan

  3 months

Other Outcomes (1)

• Deep venous thrombosis by duplex ultrasound

  30 days

Study Arms (2)

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

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

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

Drug: Diosmin / Hesperidin; Drug: Ibuprofen 400 mg

Interventions

Medtronic® Concerto® detachable coil system DEVICE

coil embolization of the reflux pathways

Also known as: concerto detachable coil system

Interventional treatment plus best chronic medical treatment

sclerosis PROCEDURE

Pelvic varices sclerosis with polidocanol foam

Also known as: Foam sclerosis with polidocanol 2%

Interventional treatment plus best chronic medical treatment

Diosmin / Hesperidin DRUG

Best chronic medial treatment

Also known as: daflon

Best chronic medical treatment alone; Interventional treatment plus best chronic medical treatment

Ibuprofen 400 mg DRUG

NSAID treatment

Also known as: Nsaid

Best chronic medical treatment alone; Interventional treatment plus best chronic medical treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clínicas Dr. Manuel Quintela: lead
• University of the Republic, Uruguay: collaborator
• Centro Cardiovascular Universitario: collaborator
• Centro Hospitalario Pereyra Rossell: collaborator

MeSH Terms

Conditions

Sclerosis

Interventions

Diosmin; Hesperidin; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavanones; Glycosides; Carbohydrates; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Sebastian Sarutte, VS

  Centro Cardiovascular Universitario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Sarutte, VS

CONTACT

+59899533449; ssarutte1@hotmail.com

Mauricio Volpi, VS

CONTACT

+59899605556; mavolpi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgery Asistant Professor

Model Details: Blind randomized clinical trial designed to compare the efficacy and safety of endovascular treatment of Pelvic congestion syndrome.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: April 24, 2020
• Study Start: October 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: October 1, 2022
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From April 2022 to april 2024
• Access Criteria: Data will be shared on request, after signing a discretion agreement.