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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.
This prospective randomized study compares the safety and efficacy of two embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook Medical) and vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibered platinum coils | Active Comparator | Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) |
|
| Vascular plugs | Experimental | Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibered platinum coils | Device |
|
| |
| Vascular plugs |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Scale | Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9). VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Improvement of Urinary Urgency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel A De Gregorio, MD, PhD | Universidad de Zaragoza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lozano Blesa University Hospital | Zaragoza | Zaragoza | 50003 | Spain |
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Patients were recruited based on physician referral in a single specialized center between January 2014 and January 2015. The 1 year follow-up period was finished in February 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fibered Platinum Coils | Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils |
| FG001 | Vascular Plugs | Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All the patients were women referred from a vascular surgeon, diagnosed of pelvic congestion syndrome and pelvic varices by transvaginal ultrasound Doppler aged over 18.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fibered Platinum Coils | Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils |
| BG001 | Vascular Plugs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Scale | Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9). VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible) | Population presenting pre-treatment pain (more than 1 in VAS) | Posted | Number | participants | 12 months |
|
Intraoperative, 3, 6, and 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibered Platinum Coils | Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migration of implant or internal device | Vascular disorders | SNOMED CT | Non-systematic Assessment | Coil migration to the pulmonary artery. Immediate retrieval during the same intervention. No complications. |
Analysis of cost dependent on the hospital/region/country. It cannot be extrapolated.
Small number of subjects to compare complication rate of both techniques.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Alicia Laborda | GITMI (University of Zaragoza) | 0034 976 76 15 49 | alaborda@unizar.es |
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| Device |
|
|
Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
| 12 months |
| 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 |
| Satisfaction With the Procedure | Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9). Patients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem. | 12 months |
| Number of Devices Used | Number of coils and number of vascular plugs used in each procedure | intraoperative |
| 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 |
| Total Intervention Duration | Total time length of the procedure, from puncture to compression (in minutes) | Intraoperative |
| Fluoroscopy Time | Total fluoroscopy time, recorded by the equipment (in minutes) | Intraoperative |
| Procedure Radiation Dose (DAP) | DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment | Intraoperative |
| Procedure Radiation Dose (AK) | AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment | Intraoperative |
| Complications | Total number of events during the procedure | intraoperative |
| Complications | Toral number of events related to the procedure in the follow-up (1 year) | 12 months |
| Need for Re-embolization | Scheduled re-embolization due to incomplete occlusion | 12 months |
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Living children | Mean | Standard Deviation | Children |
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| Pre-treatment Visual Analogue Score | VAS is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible) | Mean | Standard Deviation | units on a scale |
|
| Pain in orthostatic position | Number | participants |
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| Pain in supine position | Number | participants |
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| Dyspareunia | Number | participants |
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| Dysmenorrhea | Number | participants |
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| Urinary urgency | Number | participants |
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| History of ovarian cystic disease | Number | participants |
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| History of vaginal varicosities | Number | participants |
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| History of vulvar varicosities | Number | participants |
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| History of lower limb varices | Number | participants |
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| History of lower limb varices surgery | Number | participants |
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| Maximum right pelvic venous caliber | Mean | Standard Deviation | mm |
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| Maximum left pelvic venous caliber | Mean | Standard Deviation | mm |
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| Varicocele | Number | participants |
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| Ovarian vein reflux | Number | participants |
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| Waveform change in Valsalva's maneuver | Number | participants |
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| Secondary | Improvement of Dyspareunia | Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) | Population presenting pre-treatment dyspareunia | Posted | Number | participants | 12 months |
|
|
|
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| 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) | Population presenting pre-treatment urinary urgency | Posted | Number | participants | 12 months |
|
|
|
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| Secondary | Improvement of Dysmenorrhea | Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) | Population presenting pre-treatment dysmenorrhea | Posted | Number | participants | 12 months |
|
|
|
|
| Secondary | Satisfaction With the Procedure | Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9). Patients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
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| Secondary | Number of Devices Used | Number of coils and number of vascular plugs used in each procedure | Posted | Mean | Standard Deviation | devices | intraoperative |
|
|
|
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| 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. | Posted | Mean | Standard Deviation | US Dollars | Intraoperative |
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| Secondary | Total Intervention Duration | Total time length of the procedure, from puncture to compression (in minutes) | Posted | Mean | Standard Deviation | minutes | Intraoperative |
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| Secondary | Fluoroscopy Time | Total fluoroscopy time, recorded by the equipment (in minutes) | Posted | Mean | Standard Deviation | minutes | Intraoperative |
|
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| Secondary | Procedure Radiation Dose (DAP) | DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment | Posted | Mean | Standard Deviation | mGy*cm^2 | Intraoperative |
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|
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| Secondary | Procedure Radiation Dose (AK) | AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment | Posted | Mean | Standard Deviation | mGy | Intraoperative |
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| Secondary | Complications | Total number of events during the procedure | Posted | Number | minor events | intraoperative |
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| Secondary | Complications | Toral number of events related to the procedure in the follow-up (1 year) | Posted | Number | events | 12 months |
|
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| Secondary | Need for Re-embolization | Scheduled re-embolization due to incomplete occlusion | Posted | Number | participants | 12 months |
|
|
|
|
| 0 |
| 50 |
| 11 |
| 50 |
| EG001 | Vascular Plugs | Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs | 0 | 50 | 5 | 50 |
|
| Hematoma of neck | Musculoskeletal and connective tissue disorders | SNOMED CT | Non-systematic Assessment | Post-puncture hematoma of soft tissues of neck No treatment needed |
|
| Extravasation of blood | Vascular disorders | SNOMED CT | Non-systematic Assessment | Ovarian vein extravasation assessed during venography. No consequences. No treatment needed. |
|
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