Volunteers

Volunteers Needed – Pelvic Congestion Syndrome Research Study

We’re looking for female volunteers to take part in our Pelvic Congestion Syndrome (PCS) study to help identify if compression therapy relieves the symptoms of PCS.

If you have booked your PVE treatment or have discussed having PVE treatment already with your consultant we could still use your help with  answering simple questionnaires.

The purpose of the study?

Pelvic Congestion Syndrome (PCS) is often undiagnosed in women with pelvic pain. A lack of diagnoses is likely a result of limited awareness of the disease by both doctors and patients.

At The Whiteley Clinic, we want to raise awareness of PCS in hope that misdiagnosed women will be able to get the correct diagnosis for their condition and seek appropriate treatment.

Pelvic Vein Embolisation (PVE) with foam sclerotherapy is the current procedure used to treat women with PCS. However, many women with PCS cannot afford treatment by embolisation. This research study will give us information about the use of compression pants as an alternative treatment for women with PCS.

If compression pants prove to effectively reduce the symptoms of PCS, it would be far more cost-effective, and would make treatment for women with PCS more widely available.

The purpose of this study is to determine if, or if not, compression pants are an effective treatment for PCS, and if so, how this compares to treatment by pelvic vein embolisation.

Criteria for volunteers who have not had PVE:

We are asking women that have been diagnosed with Pelvic Congestion Syndrome and meet a selective criterion to help us with this study. This criterion includes:

• Women aged 18 – 65.
• Have had a pelvic investigation at The Whiteley Clinic confirming PCS
• Having one or more symptoms of PCS. Symptoms include dragging feeling in the pelvis on sitting and/or standing, aching/tender/painful vulval varicose veins, irritable bowel, irritable bladder, deep dyspareunia (painful sex), lower back pain, hip pain with no or very mild changes on hip x-ray.
• Being able to have a trans-vaginal scan and attend for follow-up.
• Being able to understand the study and give consent.

If you are currently pregnant, actively trying to get pregnant, planning pregnancy within the next 12 months, or are within 3 months of childbirth, we kindly ask that you do not participate in this study.

Criteria for volunteers who have an upcoming PVE treatment:

As with all research we do like to compare our data to ensure the most accurate and effective results are achieved. We ask those who have a PVE treatment booked at The Whiteley Clinic, or if you have discussed having PVE treatment with your consultant if could please take part in an easy online questionaire 1 month prior to your treatment, 1 month post treatment & 2 months post treatment.

What the study involves

The current treatment offered to women with pelvic congestion syndrome is pelvic vein embolisation with foam sclerotherapy. If opt to have this treatment, then taking part in the study will in no way affect your treatment. In this case, we will compare the change in your symptoms from before to after treatment with other women with pelvic congestion syndrome who choose to try a different treatment.  In this case, you would complete a quality of life and symptom questionnaire on your first clinic visit, the standard pelvic vein embolization with foam sclerotherapy treatment on your second clinic visit. You will then be asked to complete the Quality of life and symptom questionnaire 1 month prior, 1 month post and 2 months post  your treatment. In your last visit, you will have another trans-vaginal ultrasound scan to ensure the success of PVE. The Quality of life and Symptom Questionnaire will be online and emailed to you upon enrolment.

Compression therapy is the new treatment that we would like to trial in this study. If you opt to have compression therapy, you will complete a quality of life and symptom questionnaire on your first visit, followed by wearing normal underwear for 1 month. After this, you will wear compression pants for 1 month (in addition to leg compression if there are also symptomatic leg varicose veins). You will then be asked to complete the Quality of Life and symptom questionnaire. After this, you will wear normal underwear for 1 month and then complete the questionnaire again, with a final trans-vaginal ultrasound scan to identify any changes in pelvic vein reflux. The Quality of life and Symptom Questionnaire will be online and emailed to you upon enrolment.

Your involvement in the study would span over 3-4 months depending under which criteria category you fall under.

You are still free to withdraw at any time without providing a reason. Choosing not to participate or withdrawing from the study will in no way affect the standard of care you will receive at The Whiteley Clinic.

How to get involved

If you have read this information sheet and are excited to help us with our research at The Whiteley Clinic, please contact us either by email or telephone:

E-mail: research@thewhiteleyclinic.co.uk

Telephone: 01483 544 960

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