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）

NCT07680465 | Active Not Recruiting DMC

• 1 other identifier: ChengduUTCMpcs
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Limb Varicose Veins; Pelvic Venous Congestion Syndrome; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prevalence of Pelvic Congestion Syndrome

  Baseline

• Change in Venous Clinical Severity Score (VCSS)

  Baseline and 12 months after treatment

• Change in Pelvic Symptom Score

  Baseline and 12 months after treatment

Interventions

Pelvic MRI ， Radiofrequency Ablation DEVICE

This single-center prospective cohort study is designed to investigate a critical yet underdiagnosed link in vascular medicine: the relationship between Pelvic Congestion Syndrome (PCS) and lower limb varicose veins (LLVVs) in women. The central hypothesis posits that PCS is a prevalent, often overlooked, upstream contributor to LLVVs, and its presence negatively impacts the quality-of-life outcomes following standard endovenous intervention for the lower limbs. By applying the latest international diagnostic standards and a rigorous multidisciplinary protocol, the study aims to generate high-level evidence that can transform the clinical pathway for female patients with venous disorders.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuang, 610072, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vascular Surgery in ChengduUTCM

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: July 2, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

CN (1)