Pelvic Congestion Syndrome and Endometriosis (VES)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Endometriosis; Pelvic Congestive Syndrome

Treatments: Procedure: assessment of pain symptoms at first medical examination; Procedure: assessment of pelvic vascular insufficiency signs

Study type: Observational

Funder types: Other

Identifiers

NCT03568149

VES Study

Details and patient eligibility

About

The pelvic congestion syndrome (PCS) is a complex and multifactorial condition associated with inflammatory and hormonal etiophatogenesis similar to the endometriosis.

Furthermore, both pathologies share same clinical symptoms as chronic pelvic pain and dyspareunia.

Our hypothesis is that PCS prevalence is higher in patients with endometriosis than in those without clinical or ultrasound signs of endometriosis.

Full description

Patients undergoing routine gynecological examinations are included in the study.

Patients are divided into 2 groups:

• Group A: with endometriosis
• Group B: without clinical or ultrasound signs of endometriosis This is an observational, monocentric, prospective, exploratory study. The aim is to assess PCS incidence, associated symptoms and ultrasound characteristics in patients with endometriosis and to compare those findings to those of patients who do not present clinical or ultrasound signs of endometriosis.

The study also evaluates the correlation between:

• Type of pain symptoms (dysmenorrhea, chronic pelvic pain, ovulation pain, dyspareunia, dysuria, dyschezia) and PCS
• Pain severity (assessed according to VAS scale from 0= no pain to 10= unbearable pain) and PCS
• Symptoms and ongoing medical treatments
• History of pelvic surgery and PCS.

Ultrasound parameters of pelvic vascular insufficiency are:

• Ovarian vein diameter <4mm
• Slow ovarian blood flow (<3cm/sec)
• Retrograde blood flow
• Dilated arcuate veins communicating with pelvic varices
• The presence of pelvic varices is evaluated qualitatively as normal, moderate and serious

This evaluation includes the study of uterine and ovarian vessels, using different techniques:

• Standard 2D study: it allows to measure vessels diameter
• Vascular doppler study: it allows to evaluate flow direction and blood speed
• 3D color study: it allows a three- dimensional reconstruction of vessels and a more accurate qualitative assessment of the congestion degree.
• Ultrasound images are evaluated independently by two operators.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Group A):

• Obtaining Informed Consent
• Nulliparity
• Clinical or ultrasounds signs of endometriosis

Inclusion Criteria (Group B):

• Obtaining Informed Consent
• Nulliparity

Exclusion Criteria:

• Menopause
• Actual or previous pregnancy

Trial design

160 participants in 2 patient groups

Group A: endometriosis

Description:

assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.

Treatment:

Procedure: assessment of pain symptoms at first medical examination

Procedure: assessment of pelvic vascular insufficiency signs

Group B: no endometriosis

Description:

assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.

Treatment:

Procedure: assessment of pain symptoms at first medical examination

Procedure: assessment of pelvic vascular insufficiency signs