Prevalence of Pelvic Venous Congestion Syndrome in Female Patients With Lower Extremity Varicose Veins and Its Impact on Postoperative Quality of Life Improvement Following Radiofrequency Ablation: A Single-Center Prospective Cohort Study（PCSRFStudy）

Research Summary: Impact of Pelvic Congestion Syndrome on Lower Limb Varicose Vein Treatment

This prospective cohort study investigates the prevalence of Pelvic Congestion Syndrome (PCS) among women undergoing lower limb varicose vein ablation and its impact on post-operative quality of life.

Background PCS, a significant cause of chronic pelvic pain, results from pelvic venous insufficiency and hypertension. This pressure can transmit to the leg veins via pelvic-lower limb collaterals, potentially causing or exacerbating varicose veins. Despite this pathophysiological link, systematic PCS screening is absent in pre-operative assessments for lower limb venous surgery, leading to underdiagnosis and untreated root causes.

Objectives

Primary: Determine the prevalence of PCS in symptomatic women scheduled for radiofrequency ablation, using the latest international diagnostic criteria requiring both specific symptoms and imaging evidence while excluding other pathologies.

Secondary: Compare post-operative quality-of-life improvement between PCS-positive and PCS-negative patients and identify predictors of poorer outcomes.

Methodology This single-center prospective observational study enrolls women aged 20-60 with CEAP C2-C6 varicose veins planned for ablation. All patients undergo mandatory gynecological evaluation to rule out other pelvic diseases and a standardized pelvic MRI.

PCS diagnosis follows strict composite criteria:

Symptom Criteria: Presence of ≥2 typical symptoms (e.g., chronic pelvic pain >6 months) with a clear "venous pattern" (worsening with prolonged standing/sitting, relief with recumbency).

Imaging Criteria: MRI confirmation of significant pelvic venous dilation and tortuosity (e.g., ovarian/internal iliac veins).

Patients meeting both criteria form the PCS-positive cohort; others form the control group. Crucially, diagnosed PCS is not treated during the study phase. All receive only standard lower limb radiofrequency ablation. Follow-ups occur at 1, 6, and 12 months post-operation, with the primary outcome being the change in the vein-specific quality of life score (CIVIQ-20).

Innovation and Value This study innovates by systematically applying the latest multidisciplinary diagnostic consensus for PCS within a large venous surgery cohort and prioritizing patient-reported outcomes.

Its expected value is threefold:

To provide high-level evidence on the true prevalence of PCS in this population.

To inform clinical practice, potentially establishing a pre-operative PCS screening pathway to enable comprehensive treatment and avoid ineffective isolated leg vein procedures.

To identify PCS-positive patients as a high-risk subgroup, laying the essential groundwork for future randomized controlled trials comparing combined pelvic-lower limb interventions versus isolated leg vein treatment.

Conclusion By elucidating the association between PCS and lower limb venous disease outcomes, this study aims to shift the treatment paradigm from isolated management of leg veins to a holistic approach addressing the entire venous system in women.

Study Overview

• Status: Active, not recruiting
• Conditions: Radiofrequency Ablation; Pelvic Venous Congestion Syndrome; Lower Limb Varicose Veins
• Intervention / Treatment: Device: Pelvic MRI ， Radiofrequency Ablation

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Sichuang
    • Chengdu, Sichuang, China, 610072
      • Hospital of Chengdu University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Chronic pelvic pain is a common issue among women of reproductive age, with Pelvic Congestion Syndrome (PCS) being a significant etiological factor, second only to pelvic adhesions and endometriosis . The fundamental pathology of PCS is pelvic-genital-perineal venous insufficiency. The resulting venous hypertension not only causes chronic pelvic pain but can also become an important upstream cause for the development or exacerbation of lower limb varicose veins in women via the extensive pelvic-lower limb venous collaterals .

However, systematic screening for PCS is generally lacking in current clinical practice for female patients scheduled for lower limb venous surgery. The 2025 French multi-society consensus clearly states that the diagnosis of PCS must be based on the triad of clinical symptoms, physical examination, and imaging evidence, while excluding other gynecological diseases, opposing diagnosis based solely on imaging findings of venous dilation. This leads to a s

Description

Inclusion Criteria:

1. Female, aged 20-60 years.
2. Symptomatic lower limb varicose veins, CEAP clinical class C2-C6, planned for ultrasound-guided radiofrequency ablation.
3. Voluntary participation with signed informed consent.

Exclusion Criteria:

1. History of deep vein thrombosis or previous lower limb venous surgery.
2. Pregnancy, lactation, or planning pregnancy within 1 year.
3. Severe systemic disease or active malignancy.
4. Other established causes of chronic pelvic pain (Critical Modification).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CIVIQ-20 Score	Change in Chronic Venous Insufficiency Questionnaire (CIVIQ-20) score from baseline to 12 months after radiofrequency ablation.	Baseline and 12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Pelvic Congestion Syndrome	Prevalence of pelvic congestion syndrome diagnosed using predefined clinical and imaging criteria before treatment.	Baseline
Change in Venous Clinical Severity Score (VCSS)	Change in VCSS from baseline to 12 months after treatment.	Baseline and 12 months after treatment
Change in Pelvic Symptom Score	Change in pelvic symptom score from baseline to 12 months after treatment.	Baseline and 12 months after treatment

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ChengduUTCMpcs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No