Study to Investigate the Influence of Compression Treatment in Patients With Pelvic Congestion Syndrome (PCS)

Not Applicable

Recruiting

• Conditions: Pelvic Congestive Syndrome
• Interventions: Device: Compression pants; Device: Embolization coils

• Registration Number: NCT05553158
• Lead Sponsor: The Whiteley Clinic

Brief Summary

Pelvic vein embolization (PVE) is the current treatment procedure used to treat women with Pelvic Congestion Syndrome (PCS). This treatment is not widely available, and many women when diagnosed with PCS cannot afford treatment.

The purpose of this study is to assess whether compression therapy is an effective alternative treatment to PVE for women who are unwilling or unable to undergo treatment by PVE. Compression therapy would provide a cost-effective alternative to coil embolization.

Detailed Description

Women that book a consultation and have a trans-vaginal ultrasound scan at The Whiteley Clinic which confirms a diagnosis of Pelvic Congestion Syndrome (PCS) will be informed about the opportunity to participate in this study by their consultant (provided they also fulfil the inclusion/exclusion criteria). Potential participants will be given an information sheet and time to consider the study before giving written informed consent.

These women will be given a personalised pelvic vein embolization (PVE) treatment plan. Women that opt for PVE will form the control group for this study. Women that do not wish to have PVE and opt compression therapy will form the intervention group for this study. Alternatively, women may wish to not have any treatment and will not be enrolled in the study.

Each patient will be directly involved in the study for three months (Month 1, Month 2, Month 3). A quality of life and symptom questionnaire will be completed by all patients at the start of Month 1 (baseline), at the end of Month 2 (1-month post PVE or compression therapy), and at the end of Month 3.

Study Timeline

• Study First Submitted: 2021-09-01
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-23
• Last Update Posted: 2022-09-23
• Study Start: 2022-11-01
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 172

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compression Therapy	Compression pants	Patients will wear compression pants (with leg compression if patients also have symptomatic leg varicose veins).
Pelvic Vein Embolization (PVE)	Embolization coils	Patients will have their pelvic veins embolized in accordance with their personalised treatment plan, based on their trans-vaginal ultrasound scan. These patients form the control group.

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline in Quality of Life and Symptoms at one month post-treatment and at two months post-treatment	Baseline (start of month 0), 1 month post-treatment (end of Month 2) and two months post-treatment (end of month 3)	Patients will fill out a quality of life and symptoms questionnaire at the start of the study (baseline (month 0)). Patients will then undergo treatment after one month. A quality of life and symptoms questionnaire will then be filled out again one month after treatment (end of month 2), and again a month later (end of month 3). This questionnaire uses visual analogue scales to quantify quality of life and the severity of symptoms.

Trial Locations

Locations (1)

The Whiteley Clinic; 🇬🇧 Guildford, United Kingdom