MRI & MRV in Pelvic Congestion Syndrome in Females

Pelvic Pain Syndrome Clinical Trial

— PCS  

Official title:

MRI & MRV in Pelvic Congestion Syndrome in Females

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03252041
• Other study ID #: MRI & MRV in PCS
• Status: Not yet recruiting
• Phase: N/A
• First received: August 14, 2017
• Last updated: August 14, 2017
• Start date: September 1, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Mohamed Sayed, (M.B.B.CH)
• Phone: +201008253457
• Email: dr.abudeif[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.

Description:

In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientific understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, refinements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.

Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.

The diagnosis of PCS has usually been suggested by duplex ultrasound (US), but ultrasound imaging does not readily show the gonadal veins. Phlebography is the "gold standard" for anatomic diagnostic studies. Related mortality and morbidity are low, but patient discomfort and costs make this an unattractive routine method of diagnosis. Magnetic resonance imaging (MRI) can usually demonstrate pelvic and ovarian varices, as well as the gonadal veins.

In this prospective study, we will investigate the feasibility of using magnetic resonance venography (MRV) in the diagnosis of PCS and evaluated its accuracy and reliability in comparison to phlebography.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: October 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• All patients with signs and symptoms of PCS.

Exclusion Criteria:

• Patients with general contraindications to MRI as presence of any para-magnetic substance as pacemakers, or in severely ill patients or those with claustrophobia, arrhythmic patients.

Related Conditions & MeSH terms

• Pelvic Pain
• Pelvic Pain Syndrome
• Syndrome

Intervention

Device:
• MRI
Magnetic Resonance imaging modalities and sequences in pelvic congestion syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI and MRV in pelvic congestion syndrome in females.	To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.	one year