Endovascular Management of Pelvic Congestion Syndrome

NCT07735156 | Recruiting

• 1 other identifier: SUH-PCS-2026-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pelvic Congestion Syndrome

Outcome Measures

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)

  6 months

Secondary Outcomes (4)

• Technical success of embolization

  during the procedure

• Change in quality of life

  6 months

• Procedure-related complications

  up to 30 days after the procedure

• Quality of life improvement

  6 months

Study Arms (1)

Endovascular embolization

EXPERIMENTAL

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

Procedure: Endovascular embolization

Interventions

Endovascular embolization PROCEDURE

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

Endovascular embolization

Eligibility Criteria

• Age: 17 Years - 55 Years
• Gender Eligibility Details: Only participants who self-identify as women are eligible for enrollment in this study
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Interventional radiology unit, Sohag university hospital

Sohag, Sohag Governorate, 82524, Egypt

RECRUITING

Study Officials

• Mohammed Zaki Ali, Professor of Radiology

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Nageh Younis, M.B.B.Ch.

CONTACT

00201009800845; Ahmed.Nageh@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior resident, Radiology department

Model Details: Transcatheter embolization of incompetent ovarian and/or pelvic veins using standard embolic agents according to institutional protocol.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 29, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)