Pelvic Congestion Syndrome & Endometriosis

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03568149
Study type	Observational
Source	Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact	Diego Raimondo
Phone	00390512144385
Email	die.raimondo@gmail.com
Status	Recruiting
Phase
Start date	December 14, 2018
Completion date	August 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01931670` - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Recruiting	`NCT05648669` - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Completed	`NCT04081532` - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain	N/A
Recruiting	`NCT06101303` - Endometriosis Pain
Completed	`NCT04665414` - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed	`NCT03690765` - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting	`NCT05153512` - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting	`NCT04171297` - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting	`NCT04172272` - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures	N/A
Completed	`NCT04565470` - Strategies of Self-management of Endometriosis Symptoms
Completed	`NCT03613298` - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.	N/A
Withdrawn	`NCT05568940` - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting	`NCT03464799` - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting	`NCT03002870` - Characteristics of Patient Population With Endometriosis	N/A
Withdrawn	`NCT03272360` - Endometriosis Biomarker Discovery Study	N/A
Completed	`NCT02973854` - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Recruiting	`NCT02481739` - Laparoscopic Surgical Management of Endometriosis on Fertility	N/A
Active, not recruiting	`NCT02754648` - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve	N/A
Completed	`NCT06106932` - GnRH-a on Angiogenesis of Endometriosis	N/A
Completed	`NCT02387931` - Supplementation in Adolescent Girls With Endometriosis	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pelvic Congestion Syndrome and Endometriosis — VES

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms