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

The Whiteley Clinic

Status: Enrolling

Conditions: Pelvic Congestive Syndrome

Treatments: Device: Compression pants; Device: Embolization coils

Study type: Interventional

Funder types: Other

Identifiers

NCT05553158

TWC-AC-2021-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Females aged 18 - 65 years
• Having one or more symptoms of PCS
• Symptoms: Aching / dragging in pelvis on sitting and/or standing, aching/tender /painful vulval varicose veins, irritable bowel, irritable bladder, deep dyspareunia, low back pain, hip pain with no or very mild changes on hip x-ray.
• Able to understand study and give written consent.
• Able to have trans-vaginal ultrasound scan and attend for follow-up.

Exclusion Criteria

• Under 18 years of age or over 65 years of age
• Currently pregnant, actively trying to get pregnant, planning pregnancy within next 12 months or within 3 months of child-birth
• Current symptoms due to diagnosed gynaecological conditions
• Current or previous malignancy
• Unable or refuse to consent to trans-vaginal ultrasound scan or any other aspect of the study
• Previous abdominal or pelvic surgery (excluding diagnostic laparoscopy)
• Previous embolization of pelvic veins
• Previous deep vein thrombosis, pelvic embolisation, venous intervention in abdomen or pelvis (stent, filter)
• Any vascular malformation of the pelvis or the legs apart from that diagnosed as venous reflux disease.
• Any medical condition likely to cause death or serious ill health within the next five years.
• Any deep venous obstruction or reflux on duplex ultrasound.
• Unable to wear compression garments on lower abdomen / pelvis
• Unable to wear leg compression garments

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Pelvic Vein Embolization (PVE)

Active Comparator group

Description:

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.

Treatment:

Device: Embolization coils

Compression Therapy

Experimental group

Description:

Patients will wear compression pants (with leg compression if patients also have symptomatic leg varicose veins).

Treatment:

Device: Compression pants