Duplex US in Pelvic Congestion Syndrome in Females (PCS)

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03943381
• Collaborator: (none)
• Enrollment: 25
• Anticipated Duration (Months): 4.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Pain Syndrome	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 Design

• Study Type: Observational
• Anticipated Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Duplex US in Pelvic Congestion Syndrome in Females
• Anticipated Study Start Date: May 10, 2019
• Anticipated Primary Completion Date: Sep 1, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Outcome Measures

Primary Outcome Measures

1. Duplex US in Pelvic Congestion Syndrome in females [6 months]

   to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All patients with signs and symptoms of PCS

Exclusion Criteria:

• No

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

• Study Chair: Hossam M Galal, Assiut University, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed AbuDeif Sayed, Dr, Principal Investigator., Assiut University
• ClinicalTrials.gov Identifier: NCT03943381
• Other Study ID Numbers: Duplex US in PCS
• First Posted: May 9, 2019
• Last Update Posted: May 9, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed AbuDeif Sayed, Dr, Principal Investigator., Assiut University: PCS
• Additional relevant MeSH terms: Syndrome; Pelvic Pain

Study Results

No Results Posted as of May 9, 2019