Pelvic Congestion Syndrome and Endometriosis (VES)

Ultrasound Evaluation of the Prevalence of Pelvic Congestion Syndrome in Patients With Endometriosis

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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis; Pelvic Congestive Syndrome
• Intervention / Treatment: Procedure: assessment of pain symptoms at first medical examination; Procedure: assessment of pelvic vascular insufficiency signs

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Diego Raimondo; Phone Number: 00390512144385; Email: die.raimondo@gmail.com

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
      • Contact: Diego Raimondo; Phone Number: 00390512144385; Email: die.raimondo@gmail.com
      • Principal Investigator: Mohamed Mabrouk
      • Principal Investigator: Renato Seracchioli
      • Principal Investigator: Diego Raimondo
      • Sub-Investigator: Simona Del Forno
      • Sub-Investigator: Raffaella Iodice
      • Sub-Investigator: Manuela Mastronardi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing routine gynecological examinations in our center are included in the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: endometriosis; assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.	Procedure: assessment of pain symptoms at first medical examination; First medical examination consists of collection of medical history and standard gynecological examination (bimanual gynecological examination and abdominopelvic ultrasounds). Data regarding age, Body Mass Index, ongoing hormone therapy and pelvic pain symptoms, assessed according to Visual Analogue Scale (VAS) (from 0= no pain to 10= unbearable pain), are collected. The presence of perineal or lower limb varices and the presence and localization of evoked pain at bimanual gynecological examination are also evaluated.; Procedure: assessment of pelvic vascular insufficiency signs; Assessment of pelvic vascular insufficiency in conducted using abdominopelvic ultrasounds, according to the following parameters: 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, to measure vessels diameter; Vascular doppler study, to evaluate flow direction and blood speed; 3D color study, for a three- dimensional reconstruction of vessels and a more accurate qualitative assessment of the congestion degree.
Group B: no endometriosis; assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.	Procedure: assessment of pain symptoms at first medical examination; First medical examination consists of collection of medical history and standard gynecological examination (bimanual gynecological examination and abdominopelvic ultrasounds). Data regarding age, Body Mass Index, ongoing hormone therapy and pelvic pain symptoms, assessed according to Visual Analogue Scale (VAS) (from 0= no pain to 10= unbearable pain), are collected. The presence of perineal or lower limb varices and the presence and localization of evoked pain at bimanual gynecological examination are also evaluated.; Procedure: assessment of pelvic vascular insufficiency signs; Assessment of pelvic vascular insufficiency in conducted using abdominopelvic ultrasounds, according to the following parameters: 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, to measure vessels diameter; Vascular doppler study, to evaluate flow direction and blood speed; 3D color study, for a three- dimensional reconstruction of vessels and a more accurate qualitative assessment of the congestion degree.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pelvic congestive syndrome in patients with endometriosis	Comparison of pelvic congestive syndrome symptoms and ultrasounds characteristics, assessed by standard gynecological examination (bimanual gynecological examination and gynecological ultrasounds), between patients with endometriosis (Group A) and without clinical or ultrasound signs of endometriosis.	1 day, first medical examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between type of pain and pelvic congestive syndrome	Evaluation of the type of pain (dysmenorrhea, chronic pelvic pain, ovulation pain, dyspareunia, dysuria, dyschezia) presented by patients with pelvic congestive syndrome.	1 day, first medical examination
Correlation between pain severity and pelvic congestive syndrome	Evaluation of a possible correlation between pain severity and the presence of pelvic congestive syndrome. Pain severity is assessed according to Visual Analogue Scale (VAS scale from 0= no pain to 10= unbearable pain).	1 day, first medical examination
Correlation between symptoms and ongoing medical treatments	Evaluation of a possible correlation between symptoms and ongoing medical treatments in patients with pelvic congestive syndrome	1 day, first medical examination
Correlation between history of pelvic surgery and pelvic congestive syndrome	Evaluation of a possible correlation between history of pelvic surgery and the presence of pelvic congestive syndrome	1 day, first medical examination

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Endometriosis
• Other Study ID Numbers: VES Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No