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

NCT05553158 | Unknown

• 1 other identifier: TWC-AC-2021-03
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Congestive Syndrome

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

Device: Embolization coils

Compression Therapy

EXPERIMENTAL

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

Device: Compression pants

Interventions

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.

Compression Therapy

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.

Pelvic Vein Embolization (PVE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Whiteley Clinic: lead
• Bauerfeind: collaborator

Study Sites (1)

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

RECRUITING

Study Officials

• Mark S Whiteley, MS FRCS(Gen) MBBS

  The Whiteley Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark S Whiteley, MS FRCS (Gen) MBBS

CONTACT

0330 058 1850; mark@thewhiteleyclinic.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 23, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)