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

NCT ID: NCT05553158

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-11-30

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.

Conditions

Pelvic Congestive Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pelvic Vein Embolization (PVE)

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.

Group Type: ACTIVE_COMPARATOR

Embolization coils

Intervention Type: 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.

Compression Therapy

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

Group Type: EXPERIMENTAL

Compression pants

Intervention Type: 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.

Interventions

Compression pants

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.

Intervention Type: DEVICE

Embolization coils

Embolization coils are used to block the veins they are positioned in. This is a standard treatment offered to patients at The Whiteley Clinic.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Whiteley Clinic

OTHER

Sponsor Role: lead

Bauerfeind

UNKNOWN

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark S Whiteley, MS FRCS(Gen) MBBS

Role: PRINCIPAL_INVESTIGATOR

The Whiteley Clinic

Locations

The Whiteley Clinic

Guildford, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Mark S Whiteley, MS FRCS (Gen) MBBS

Role: CONTACT

mark@thewhiteleyclinic.co.uk

0330 058 1850

Facility Contacts

Mark S Whiteley, MS FRCS (Gen) MBBS

Role: primary

mark@thewhiteleyclinic.co.uk

0330 0581 850

Other Identifiers

TWC-AC-2021-03

Identifier Type: -

Identifier Source: org_study_id