Pelvic Pain SyndromeNCT03943381
Duplex US in Pelvic Congestion Syndrome in Females (PCS)
An observational study of Pelvic Pain Syndrome, run by Assiut University.
Trial summary
To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain Syndrome
- What is being tested?
- Duplex US
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2019to Oct 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome
Who may be able to join
- All patients with signs and symptoms of PCS
Who cannot join
- No
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Duplex US in Pelvic Congestion Syndrome in Females
To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome
Read the detailed description
- In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientific understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, refinements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.
- Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.
Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening \& grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization
- Conditions
- Pelvic Pain Syndrome
- Being tested
- Duplex US
- Keywords
- PCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex USDevice
Duplex US (Caliper, wave forms...)in evaluation of Pelvic Veins (namely left ovarian vein). in pelvic congestion syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Duplex US in Pelvic Congestion Syndrome in females
to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start10 May 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed AbuDeif Sayed, Assiut University
- Investigators
- Hossam M Galal, Study chair, Assiut University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943381
- Sponsor's protocol ID
- Duplex US in PCS
- Status last verified
- Apr 2019
- First submitted
- 7 May 2019
- Last updated
- 9 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be shared when finished
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duplex US in Pelvic Congestion Syndrome in Females
- ClinicalTrials.gov ID
- NCT03943381
- Acronym / sponsor ID
- Duplex US in PCS
- Conditions
- Pelvic Pain Syndrome
- Keywords
- PCS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 May 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 9 May 2019 (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.
To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome
Detailed description
- In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientific understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, refinements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.
- Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.
Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening \& grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome
Key inclusion criteria (1 listed)
- All patients with signs and symptoms of PCS
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Duplex USDuplex US (Caliper, wave forms...)in evaluation of Pelvic Veins (namely left ovarian vein). in pelvic congestion syndrome | Device | – |
Primary outcome
Duplex US in Pelvic Congestion Syndrome in females
Time frame: 6 months
to investigate the feasibility of Duplex US in diagnosis of Pelvic Congestion Syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Individual participant dataSharing planned: Undecided. to be shared when finished
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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.
Hossam M Galal study chair
Assiut University, Egypt
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Pain Syndrome, run by Assiut University.
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 1 inclusion and 1 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 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed A Sayed (+201008253457, dr.abudeif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duplex US in Pelvic Congestion Syndrome in females (time frame: 6 months). 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 9 May 2019.