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| Name | Class |
|---|---|
| Bauerfeind | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Vein Embolization (PVE) | Active Comparator | 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. |
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| Compression Therapy | Experimental | Patients will wear compression pants (with leg compression if patients also have symptomatic leg varicose veins). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression pants | Device | Similar to compression stockings for the legs which are designed to apply pressure to improve venous return in the legs, compression pants have been designed to apply pressure to pelvic veins to improve the symptoms of Pelvic Congestion Syndrome. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Quality of Life and Symptoms at one month post-treatment and at two months post-treatment | 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. | Baseline (start of month 0), 1 month post-treatment (end of Month 2) and two months post-treatment (end of month 3) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark S Whiteley, MS FRCS (Gen) MBBS | Contact | 0330 058 1850 | mark@thewhiteleyclinic.co.uk |
| Name | Affiliation | Role |
|---|---|---|
| Mark S Whiteley, MS FRCS(Gen) MBBS | The Whiteley Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Whiteley Clinic | Recruiting | Guildford | GU2 7RF | United Kingdom |
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There are two arms in this study: control arm and interventional arm. Participants in the control arm will have pelvic vein embolization and participants in the interventional arm will have compression therapy.
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| Embolization coils | Device | Embolization coils are used to block the veins they are positioned in. This is a standard treatment offered to patients at The Whiteley Clinic. |
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