Pelvic Congestion Syndrome and Endometriosis

• Conditions: Endometriosis; Pelvic Congestive Syndrome
• Interventions: Procedure: assessment of pain symptoms at first medical examination; Procedure: assessment of pelvic vascular insufficiency signs

• Registration Number: NCT03568149
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-06-26
• Study Start: 2018-12-14
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12
• Primary Completion: 2019-07
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

• Menopause
• Actual or previous pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: endometriosis	assessment of pain symptoms at first medical examination	assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.
Group A: endometriosis	assessment of pelvic vascular insufficiency signs	assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.
Group B: no endometriosis	assessment of pain symptoms at first medical examination	assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.
Group B: no endometriosis	assessment of pelvic vascular insufficiency signs	assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs.

Primary Outcome Measures

Name	Time	Method
Incidence of pelvic congestive syndrome in patients with endometriosis	1 day, first medical examination	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between pain severity and pelvic congestive syndrome	1 day, first medical examination	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).
Correlation between symptoms and ongoing medical treatments	1 day, first medical examination	Evaluation of a possible correlation between symptoms and ongoing medical treatments in patients with pelvic congestive syndrome
Correlation between type of pain and pelvic congestive syndrome	1 day, first medical examination	Evaluation of the type of pain (dysmenorrhea, chronic pelvic pain, ovulation pain, dyspareunia, dysuria, dyschezia) presented by patients with pelvic congestive syndrome.
Correlation between history of pelvic surgery and pelvic congestive syndrome	1 day, first medical examination	Evaluation of a possible correlation between history of pelvic surgery and the presence of pelvic congestive syndrome

Trial Locations

Locations (1)

Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital; 🇮🇹 Bologna, BO, Italy