Ignite Creation Date:
2024-05-06 @ 2:32 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04358497
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2020-01-17
Brief Title:
Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
Sponsor:
Hospital de Clínicas Dr Manuel Quintela
Organization:
Hospital de Clínicas Dr Manuel Quintela
Study Overview
Official Title:
Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDPCS
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 patients 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
There is no standard approach to managing PCS According to expert recommendations therapies should be individualized according to the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None