Status:
UNKNOWN
Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
Lead Sponsor:
Hospital de Clínicas Dr. Manuel Quintela
Collaborating Sponsors:
University of the Republic, Uruguay
Centro Cardiovascular Universitario
Conditions:
Pelvic Congestive Syndrome
Pelvic Varices
Eligibility:
FEMALE
Phase:
PHASE4
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...
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 heav...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04358497
Start Date
October 1 2020
End Date
October 1 2022
Last Update
April 24 2020
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