MRI & MRV in Pelvic Congestion Syndrome in Females (PCS)

August 14, 2017 updated by: Mohamed AbuDeif Sayed, Assiut University
To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI and MRV in pelvic congestion syndrome in females.
Time Frame: one year
To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Hossam Galal, ass prof, Assiut university, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2017

Primary Completion (ANTICIPATED)

September 30, 2018

Study Completion (ANTICIPATED)

October 31, 2018

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (ACTUAL)

August 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI & MRV in PCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

to be shared when finished

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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