ClinicalTrials.gg
Status unknownNCT03252041PCSUpdated Aug 17, 2017

MRI & MRV in Pelvic Congestion Syndrome in Females

An observational study in Pelvic Pain Syndrome, sponsored by Assiut University. Status unknown. Open to female participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
25 Years to 55 Years
Sex
Female
01

Study summary

To investigate the feasibility of MRI and MRV 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.

The diagnosis of PCS has usually been suggested by duplex ultrasound (US), but ultrasound imaging does not readily show the gonadal veins. Phlebography is the "gold standard" for anatomic diagnostic studies. Related mortality and morbidity are low, but patient discomfort and costs make this an unattractive routine method of diagnosis. Magnetic resonance imaging (MRI) can usually demonstrate pelvic and ovarian varices, as well as the gonadal veins.

In this prospective study, we will investigate the feasibility of using magnetic resonance venography (MRV) in the diagnosis of PCS and evaluated its accuracy and reliability in comparison to phlebography.

02

Conditions studied

  • Pelvic Pain Syndrome

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Keywords

  • PCS
03

In context

Pelvic Pain

376 studies on the registry are indexed under Pelvic Pain; 90 are open to participants now.

This study's planned enrollment of 25 is below the median of 100 across 83 observational studies indexed under Pelvic Pain.

Browse Pelvic Pain studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients with signs and symptoms of PCS.

Exclusion criteria

Exclusion Criteria:

  • Patients with general to MRI as presence of any para-magnetic substance as pacemakers, or in severely ill patients or those with claustrophobia, arrhythmic patients.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Interventions

  • DeviceMRI

    Magnetic Resonance imaging modalities and sequences in pelvic congestion syndrome

06

What researchers measure

Primary outcomes

  1. MRI and MRV in pelvic congestion syndrome in females.

    To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — to be shared when finished

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2017; primary completion for Sep 2018, 12 months later.

Of 33 observational studies under Pelvic Pain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2017
First posted
Aug 17, 2017
StartEst.
Sep 1, 2017
Primary completionEst.
Sep 30, 2018
CompletionEst.
Oct 31, 2018
Last update
Aug 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03252041
Lead sponsor
Assiut University
Responsible party
Mohamed AbuDeif Sayed (Dr, Assiut University) — Principal investigator
First posted
Aug 17, 2017
Start date
Sep 1, 2017 (estimated)
Primary completion
Sep 30, 2018 (estimated)
Completion
Oct 31, 2018 (estimated)
Last update
Aug 17, 2017

Study contacts

Mohamed Sayed, (M.B.B.CH)
Contact
dr.abudeif@gmail.com
+201008253457
Noha Attia, lect
Contact
nohamohamedali@yahoo.com
+201001238435
Hossam Galal, ass prof
study chair · Assiut University, Egypt

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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