Pelvic Congestive SyndromeNCT05553158
Study to Investigate the Influence of Compression Treatment in Patients With Pelvic Congestion Syndrome (PCS)
A study testing Compression pants and Embolization coils in people with Pelvic Congestive Syndrome, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pelvic Congestive Syndrome
- What is being tested?
- Compression pants and Embolization coils
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2022to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Whiteley Clinic
Guildford, GU2 7RF
Mark S Whiteley, MS FRCS (Gen) MBBS, 0330 0581 850, mark@thewhiteleyclinic.co.uk
About this study
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.
Read the 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.
- Conditions
- Pelvic Congestive Syndrome
- Being tested
- Compression pants, Embolization coils
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression pantsDevice
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 coilsDevice
Embolization coils are used to block the veins they are positioned in. This is a standard treatment offered to patients at The Whiteley Clinic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Embolization coils |
| Compression Therapy | Experimental | Patients will wear compression pants (with leg compression if patients also have symptomatic leg varicose veins). Receives: Device: Compression pants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (start of month 0), 1 month post-treatment (end of Month 2) and two months post-treatment (end of month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Nov 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestive SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Bauerfeind
- Responsible party
- Sponsor
- Investigators
- Mark S Whiteley, MS FRCS(Gen) MBBS, Principal investigator, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553158
- Sponsor's protocol ID
- TWC-AC-2021-03
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Influence of Compression Treatment in Patients With Pelvic Congestion Syndrome (PCS)
- ClinicalTrials.gov ID
- NCT05553158
- Acronym / sponsor ID
- TWC-AC-2021-03
- Conditions
- Pelvic Congestive Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Collaborators
- Bauerfeind
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pelvic Vein Embolization (PVE) | Active comparator | Device: Embolization coilsPatients 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. |
| Compression Therapy | Experimental | Device: Compression pantsPatients will wear compression pants (with leg compression if patients also have symptomatic leg varicose veins). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression pantsSimilar 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. | Device | Compression Therapy |
| Embolization coilsEmbolization coils are used to block the veins they are positioned in. This is a standard treatment offered to patients at The Whiteley Clinic. | Device | Pelvic Vein Embolization (PVE) |
Primary outcome
Mean Change from Baseline in Quality of Life and Symptoms at one month post-treatment and at two months post-treatment
Time frame: Baseline (start of month 0), 1 month post-treatment (end of Month 2) and two months post-treatment (end of month 3)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Whiteley, MS FRCS(Gen) MBBS principal investigator
The Whiteley Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression pants and Embolization coils in people with Pelvic Congestive Syndrome, run by The Whiteley Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark S Whiteley, MS FRCS (Gen) MBBS (0330 058 1850, mark@thewhiteleyclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Quality of Life and Symptoms at one month post-treatment and at two months post-treatment (time frame: Baseline (start of month 0), 1 month post-treatment (end of Month 2) and two months post-treatment (end of month 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.