Clinical trial NCT05553158: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Congestive Syndrome
Lead sponsor: The Whiteley Clinic
Sponsor class: OTHER
Collaborators: name: Bauerfeind
First posted: 2022-09-23
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Change from Baseline in Quality of Life and Symptoms at one month post-treatment and at two months post-treatment
timeFrame: Baseline (start of month 0), 1 month post-treatment (end of Month 2) and two months post-treatment (end of month 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: The Whiteley Clinic
Study officials:
affiliation: The Whiteley Clinic
name: Mark S Whiteley, MS FRCS(Gen) MBBS
role: PRINCIPAL_INVESTIGATOR
References: