Duplex US in Pelvic Congestion Syndrome in Females (PCS)

Duplex US in Pelvic Congestion Syndrome in Females

To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome

Study Overview

• Status: Unknown
• Conditions: Pelvic Pain Syndrome
• Intervention / Treatment: Device: Duplex US

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.

Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening & grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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:

• No

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duplex US in Pelvic Congestion Syndrome in females	to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome	6 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Hossam M Galal, Assiut university, Egypt

Study record dates

Study Major Dates

• Study Start (Anticipated): May 10, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: PCS
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease; Syndrome; Pelvic Pain
• Other Study ID Numbers: Duplex US 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