Pelvic Congestion Syndrome Clinical Trial
Official title:
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 2016 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent - Presence of chronic abdominal or pelvic pain for more than 6 months - >6 mm pelvic venous caliber measured by transvaginal US - Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US Exclusion Criteria: - Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma - Glomerular filtration rate <60 ml/min - History of contrast reaction - Patients not able to be followed up for at least one year |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Lozano Blesa University Hospital | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Group of Research in Minimally Invasive Techniques |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in pain | Decrease in subjective pain assessed by VAS (visual analogue scale) | 12 months | No |
Secondary | Improvement of dyspareunia | Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) | 12 months | No |
Secondary | Improvement of urinary urgency | Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) | 12 months | No |
Secondary | Improvement of dysmenorrhea | Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) | 12 months | No |
Secondary | Satisfaction with the procedure | Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9) | 12 months | No |
Secondary | Number of devices used | Number of coils and number of vascular plugs used in each procedure | intraoperative | No |
Secondary | Cost of treatment | Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay. | Intraoperative | No |
Secondary | Total intervention duration | Total time length of the procedure, from puncture to compression (in minutes) | Intraoperative | No |
Secondary | Fluoroscopy time | Total fluoroscopy time, recorded by the equipment (in minutes) | Intraoperative | Yes |
Secondary | Procedure radiation dose (DAP) | DAP, dose area product of the intervention, (in mGy·cm2), recorded by fluoroscopy equipment | Intraoperative | Yes |
Secondary | Procedure radiation dose (AK) | AK, total air kerma of the intervention (in Gy), recorded by fluoroscopy equipment | Intraoperative | Yes |
Secondary | Complications | Overall complications of the procedure | intraoperative | Yes |
Secondary | Complications | 1 year overall complications related to procedure | 12 months | Yes |
Secondary | Need for re-embolization | Scheduled re-embolization due to incomplete occlusion | 12 months | No |
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