An interventional study of Compression pants and Embolization coils in Pelvic Congestive Syndrome, sponsored by The Whiteley Clinic. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by The Whiteley Clinic · Not applicable, Interventional, and Treatment
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.
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.
The Whiteley Clinic is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients will wear compression pants (with leg compression if patients also have symptomatic leg varicose veins).
Device: 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.
Embolization coils are used to block the veins they are positioned in. This is a standard treatment offered to patients at The Whiteley Clinic.
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.
Time frame: Baseline (start of month 0), 1 month post-treatment (end of Month 2) and two months post-treatment (end of month 3)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2022; primary completion for Nov 2024, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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