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

Primary Purpose

Pelvic Congestive Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Compression pants

Embolization coils

About this trial

This is an interventional treatment trial for Pelvic Congestive Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The Whiteley ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pelvic Vein Embolization (PVE)

Compression Therapy

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05553158

First Posted

September 1, 2021

Last Updated

September 22, 2022

Sponsor

The Whiteley Clinic

Collaborators

Bauerfeind

1. Study Identification

Unique Protocol Identification Number

NCT05553158

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Anticipated)

Primary Completion Date

November 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Whiteley Clinic

Collaborators

Bauerfeind

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Congestive Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pelvic Vein Embolization (PVE)

Arm Type

Active Comparator

Arm 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.

Arm Title

Compression Therapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Compression pants

Intervention Description

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

Intervention Name(s)

Embolization coils

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Change from Baseline in Quality of Life and Symptoms at one month post-treatment and at two months post-treatment

Description

Time Frame

Baseline (start of month 0), 1 month post-treatment (end of Month 2) and two months post-treatment (end of month 3)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mark S Whiteley, MS FRCS (Gen) MBBS

Phone

0330 058 1850

mark@thewhiteleyclinic.co.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark S Whiteley, MS FRCS(Gen) MBBS

Organizational Affiliation

The Whiteley Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Whiteley Clinic

City

Guildford

ZIP/Postal Code

GU2 7RF

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mark S Whiteley, MS FRCS (Gen) MBBS

Phone

0330 0581 850

mark@thewhiteleyclinic.co.uk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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