Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05553158
Status:
RECRUITING
Last Update Posted:
2022-09-23
First Post:
2021-09-01
Brief Title:
Study to Investigate the Influence of Compression Treatment in Patients With Pelvic Congestion Syndrome PCS
Sponsor:
The Whiteley Clinic
Organization:
The Whiteley Clinic
Study Overview
Official Title:
Study to Investigate the Influence of Compression Treatment in Patients With Pelvic Congestion Syndrome PCS
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 inclusionexclusion 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None