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RecruitingNCT07735156PCSIRUpdated Jul 29, 2026

Endovascular Management of Pelvic Congestion Syndrome

An interventional study of Endovascular embolization in Pelvic Congestion Syndrome, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to female participants aged 17 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2026, registered Jul 2026).
  • Started Jan 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
17 Years to 55 Years
Sex
Female
01

Study 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 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

02

Conditions studied

  • Pelvic Congestion Syndrome
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

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

04

Who can participate

Ages eligible
17 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Endovascular embolization

    Female patients with pelvic congestion syndrome undergoing endovascular embolization of incompetent ovarian and/or pelvic veins

    Procedure: Endovascular embolization

Interventions

  • ProcedureEndovascular embolization

    Transcatheter embolization of incompetent ovarian and/or pelvic veins using standard embolic materials according to institutional practice to treat pelvic congestion syndrome.

    Also known as: Ovarian vein embolization

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

Secondary outcomes

  1. 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 (%)

    Time frame: during the procedure

  2. 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

    Time frame: 6 months

  3. Procedure-related complications

    Assessment of major and minor complications according to the Society of Interventional Radiology (SIR) classification.

    Time frame: up to 30 days after the procedure

  4. Quality of life improvement

    Improvement in patient's quality of life following embolization

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Interventional radiology unit, Sohag university hospital
    Sohag, Sohag Governorate 82524, Egypt
    • Ahmed Nageh Younis, M.B.B.Ch. · Contact · Ahmed.Nageh@med.sohag.edu.eg · 00201009800845
    • Mohammed Zaki Ali, Professor of radiology · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07735156
Lead sponsor
Sohag University
Responsible party
Ahmed Nageh Younis (Senior resident, Radiology department, Sohag University) — Principal investigator
First posted
Jul 29, 2026
Start date
Jan 14, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Jun 20, 2027 (estimated)
Last update
Jul 29, 2026

Study contacts

Ahmed Nageh Younis, M.B.B.Ch.
Contact
Ahmed.Nageh@med.sohag.edu.eg
00201009800845
Mohammed Zaki Ali, Professor of Radiology
principal investigator · Sohag University

Oversight

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

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