Pelvic Congestive SyndromeVESNCT03568149
Pelvic Congestion Syndrome and Endometriosis
An observational study of Pelvic Congestive Syndrome and Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pelvic Congestive Syndrome, Endometriosis
- What is being tested?
- assessment of pain symptoms at first medical examination and assessment of pelvic vascular insufficiency signs
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 14 Dec 2018to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients undergoing routine gynecological examinations in our center are included in the study.
Who may be able to join
- Obtaining Informed Consent
- Nulliparity
- Clinical or ultrasounds signs of endometriosis
- Obtaining Informed Consent
- Nulliparity
Who cannot join
- Menopause
- Actual or previous pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Bologna, BO, 40138
Diego Raimondo, 00390512144385, die.raimondo@gmail.com
Mohamed Mabrouk
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Congestive Syndrome, Endometriosis
- Being tested
- assessment of pain symptoms at first medical examination, assessment of pelvic vascular insufficiency signs
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of pain symptoms at first medical examinationProcedure or surgery
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.
assessment of pelvic vascular insufficiency signsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: endometriosis | assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs. Receives: Procedure: assessment of pain symptoms at first medical examination; Procedure: assessment of pelvic vascular insufficiency signs | |
| Group B: no endometriosis | assessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs. Receives: Procedure: assessment of pain symptoms at first medical examination; Procedure: assessment of pelvic vascular insufficiency signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day, first medical examination
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 1 day, first medical examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start14 Dec 2018
- Primary completionJul 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestive SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mabrouk, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568149
- Sponsor's protocol ID
- VES Study
- Acronym
- VES
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of the Prevalence of Pelvic Congestion Syndrome in Patients With Endometriosis
- ClinicalTrials.gov ID
- NCT03568149
- Acronym / sponsor ID
- VES / VES Study
- Conditions
- Pelvic Congestive Syndrome, Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: endometriosis | – | Procedure: assessment of pain symptoms at first medical examination, Procedure: assessment of pelvic vascular insufficiency signsassessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs. |
| Group B: no endometriosis | – | Procedure: assessment of pain symptoms at first medical examination, Procedure: assessment of pelvic vascular insufficiency signsassessment of pain symptoms at first medical examination; assessment of pelvic vascular insufficiency signs. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing routine gynecological examinations in our center are included in the study.
Key inclusion criteria (5 listed)
- Obtaining Informed Consent
- Nulliparity
- Clinical or ultrasounds signs of endometriosis
- Obtaining Informed Consent
- Nulliparity
Key exclusion criteria (2 listed)
- Menopause
- Actual or previous pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of pain symptoms at first medical examinationFirst 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 or surgery | Group A: endometriosis, Group B: no endometriosis |
| assessment of pelvic vascular insufficiency signsAssessment 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. | Procedure or surgery | Group A: endometriosis, Group B: no endometriosis |
Primary outcome
Incidence of pelvic congestive syndrome in patients with endometriosis
Time frame: 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.
4 secondary outcomes
Correlation between type of pain and pelvic congestive syndrome
Time frame: 1 day, first medical examination
Correlation between pain severity and pelvic congestive syndrome
Time frame: 1 day, first medical examination
Correlation between symptoms and ongoing medical treatments
Time frame: 1 day, first medical examination
Correlation between history of pelvic surgery and pelvic congestive syndrome
Time frame: 1 day, first medical examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Congestive Syndrome and Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Raimondo (00390512144385, die.raimondo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pelvic congestive syndrome in patients with endometriosis (time frame: 1 day, first medical examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.