Pelvic Congestion SyndromePCSIRNCT07735156
Endovascular Management of Pelvic Congestion Syndrome
A study testing Endovascular embolization in people with Pelvic Congestion Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
Pelvic congestion syndrome (PCS) is a common cause of chronic pelvic pain in women and is associated with pelvic venous insufficiency. This prospective interventional study aims to evaluate the safety and clinical effectiveness of endovascular embolization in relieving symptoms and improving quality of life in women… Read more about this study
- Who is it for?
- Ages 17 to 55 years, women only
- Conditions the study is for
- Pelvic Congestion Syndrome
- What is being tested?
- Endovascular embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2026to 20 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female patients aged 18 years or older.
- Chronic pelvic pain for more than 6 months.
- Clinical suspicion of pelvic congestion syndrome.
- Imaging findings consistent with pelvic congestion syndrome on Doppler ultrasound, CT venography, MR venography, or catheter venography.
- Patients willing to undergo endovascular embolization.
- Written informed consent obtained
Who cannot join
- Pregnancy.
- Active pelvic inflammatory disease.
- Known pelvic malignancy.
- Chronic pelvic pain due to other identifiable causes (e.g., endometriosis, large uterine fibroids).
- Contraindication to iodinated contrast media.
- Severe renal impairment.
- Uncorrectable coagulation disorders.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Interventional radiology unit, Sohag university hospital
Sohag, Sohag Governorate, 82524
Ahmed Nageh Younis, M.B.B.Ch., 00201009800845, Ahmed.Nageh@med.sohag.edu.eg
Mohammed Zaki Ali, Professor of radiology
About this study
Official title: Role of Endovascular Management of Pelvic Congestion Syndome
Pelvic congestion syndrome (PCS) is a common cause of chronic pelvic pain in women and is associated with pelvic venous insufficiency. This prospective interventional study aims to evaluate the safety and clinical effectiveness of endovascular embolization in relieving symptoms and improving quality of life in women diagnosed with PCS
Read the detailed description
Pelvic congestion syndrome is characterized by chronic pelvic pain resulting from pelvic venous reflux and varicosities. Endovascular embolization has emerged as a minimally invasive treatment with promising clinical outcomes. This prospective interventional study will evaluate the efficacy and safety of endovascular embolization in female patients with clinically suspected and imaging-confirmed PCS. Patients will undergo clinical assessment, imaging evaluation, and endovascular treatment according to standard institutional protocols. Clinical outcomes will be assessed using pain scores and symptom improvement during follow-up, while procedural success, technical outcomes, and complications will also be recorded
- Conditions
- Pelvic Congestion Syndrome
- Being tested
- Endovascular embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular embolizationProcedure or surgery
Also called Ovarian vein embolization
Transcatheter embolization of incompetent ovarian and/or pelvic veins using standard embolic materials according to institutional practice to treat pelvic congestion syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular embolization | Experimental | Female patients with pelvic congestion syndrome undergoing endovascular embolization of incompetent ovarian and/or pelvic veins Receives: Procedure: Endovascular embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pelvic pain after endovascular embolization
Change in pelvic pain measured using the Visual Analog Scale (VAS, 0-10), comparing baseline with 6-month follow-up.
Unit of Measure:
VAS score (0-10)
Measured: 6 months
Secondary outcomes (4)
Technical success of embolization
Percentage of patients with successful catheterization and complete embolization of all incompetent ovarian and/or pelvic veins during the procedure.
Unit:
Percentage of participants (%)
Measured: during the procedure
Change in quality of life
Change in quality of life assessed using the Pelvic Venous Clinical Severity Score (PVCSS) or another predefined questionnaire at baseline and 6 months.
Unit:
Score
Measured: 6 months
Procedure-related complications
Assessment of major and minor complications according to the Society of Interventional Radiology (SIR) classification.
Measured: up to 30 days after the procedure
Quality of life improvement
Improvement in patient's quality of life following embolization
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 posted29 Jul 2026
- Study start14 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestion SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Transcatheter embolization of incompetent ovarian and/or pelvic veins using standard embolic agents according to institutional protocol.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Nageh Younis, Sohag University
- Investigators
- Mohammed Zaki Ali, Professor of Radiology, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735156
- Sponsor's protocol ID
- SUH-PCS-2026-01
- Acronym
- PCSIR
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endovascular Management of Pelvic Congestion Syndome
- ClinicalTrials.gov ID
- NCT07735156
- Acronym / sponsor ID
- PCSIR / SUH-PCS-2026-01
- Conditions
- Pelvic Congestion Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 29 Jul 2026 (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.
Pelvic congestion syndrome (PCS) is a common cause of chronic pelvic pain in women and is associated with pelvic venous insufficiency. This prospective interventional study aims to evaluate the safety and clinical effectiveness of endovascular embolization in relieving symptoms and improving quality of life in women diagnosed with PCS
Detailed description
Pelvic congestion syndrome is characterized by chronic pelvic pain resulting from pelvic venous reflux and varicosities. Endovascular embolization has emerged as a minimally invasive treatment with promising clinical outcomes. This prospective interventional study will evaluate the efficacy and safety of endovascular embolization in female patients with clinically suspected and imaging-confirmed PCS. Patients will undergo clinical assessment, imaging evaluation, and endovascular treatment according to standard institutional protocols. Clinical outcomes will be assessed using pain scores and symptom improvement during follow-up, while procedural success, technical outcomes, and complications will also be recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Transcatheter embolization of incompetent ovarian and/or pelvic veins using standard embolic agents according to institutional protocol.
| Arm | Type | Receives |
|---|---|---|
| Endovascular embolization | Experimental | Procedure: Endovascular embolizationFemale patients with pelvic congestion syndrome undergoing endovascular embolization of incompetent ovarian and/or pelvic veins |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Female patients aged 18 years or older.
- Chronic pelvic pain for more than 6 months.
- Clinical suspicion of pelvic congestion syndrome.
- Imaging findings consistent with pelvic congestion syndrome on Doppler ultrasound, CT venography, MR venography, or catheter venography.
- Patients willing to undergo endovascular embolization.
Key exclusion criteria (8 listed)
- Pregnancy.
- Active pelvic inflammatory disease.
- Known pelvic malignancy.
- Chronic pelvic pain due to other identifiable causes (e.g., endometriosis, large uterine fibroids).
- Contraindication to iodinated contrast media.
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 |
|---|---|---|
| Endovascular embolizationAlso: Ovarian vein embolizationTranscatheter embolization of incompetent ovarian and/or pelvic veins using standard embolic materials according to institutional practice to treat pelvic congestion syndrome. | Procedure or surgery | Endovascular embolization |
Primary outcome
Improvement in pelvic pain after endovascular embolization
Time frame: 6 months
Change in pelvic pain measured using the Visual Analog Scale (VAS, 0-10), comparing baseline with 6-month follow-up. Unit of Measure: VAS score (0-10)
4 secondary outcomes
Technical success of embolization
Time frame: during the procedure
Change in quality of life
Time frame: 6 months
Procedure-related complications
Time frame: up to 30 days after the procedure
Quality of life improvement
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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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.
Mohammed Zaki Ali, Professor of Radiology principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular embolization in people with Pelvic Congestion Syndrome, run by Sohag University at 1 site in Egypt.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Nageh Younis, M.B.B.Ch. (00201009800845, Ahmed.Nageh@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in pelvic pain after endovascular embolization (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 29 Jul 2026.