Back to resultsFibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Primary Purpose
Pelvic Congestion Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Fibered platinum coils
Vascular plugs
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Congestion Syndrome focused on measuring Pelvic Congestion Syndrome, Pelvic Venous Insufficiency, Chronic pelvic pain
Eligibility Criteria
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
Sites / Locations
- Lozano Blesa University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fibered platinum coils
Vascular plugs
Arm Description
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Improvement of Dyspareunia
Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
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)
Improvement of Dysmenorrhea
Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
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.
Number of Devices Used
Number of coils and number of vascular plugs used in each procedure
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.
Total Intervention Duration
Total time length of the procedure, from puncture to compression (in minutes)
Fluoroscopy Time
Total fluoroscopy time, recorded by the equipment (in minutes)
Procedure Radiation Dose (DAP)
DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment
Procedure Radiation Dose (AK)
AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment
Complications
Total number of events during the procedure
Complications
Toral number of events related to the procedure in the follow-up (1 year)
Need for Re-embolization
Scheduled re-embolization due to incomplete occlusion
Full Information
NCT ID
NCT02796092
First Posted
May 27, 2016
Last Updated
February 28, 2017
Sponsor
Group of Research in Minimally Invasive Techniques
1. Study Identification
Unique Protocol Identification Number
NCT02796092
Brief Title
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Official Title
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Group of Research in Minimally Invasive Techniques
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Congestion Syndrome
Keywords
Pelvic Congestion Syndrome, Pelvic Venous Insufficiency, Chronic pelvic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibered platinum coils
Arm Type
Active Comparator
Arm Description
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Arm Title
Vascular plugs
Arm Type
Experimental
Arm Description
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Intervention Type
Device
Intervention Name(s)
Fibered platinum coils
Other Intervention Name(s)
Nester coils
Intervention Type
Device
Intervention Name(s)
Vascular plugs
Other Intervention Name(s)
Amplatzer vascular plugs
Primary Outcome Measure Information:
Title
Change in Pain Scale
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvement of Dyspareunia
Description
Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Time Frame
12 months
Title
Improvement of Urinary Urgency
Description
Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Time Frame
12 months
Title
Improvement of Dysmenorrhea
Description
Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Time Frame
12 months
Title
Satisfaction With the Procedure
Description
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.
Time Frame
12 months
Title
Number of Devices Used
Description
Number of coils and number of vascular plugs used in each procedure
Time Frame
intraoperative
Title
Cost of Treatment
Description
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.
Time Frame
Intraoperative
Title
Total Intervention Duration
Description
Total time length of the procedure, from puncture to compression (in minutes)
Time Frame
Intraoperative
Title
Fluoroscopy Time
Description
Total fluoroscopy time, recorded by the equipment (in minutes)
Time Frame
Intraoperative
Title
Procedure Radiation Dose (DAP)
Description
DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment
Time Frame
Intraoperative
Title
Procedure Radiation Dose (AK)
Description
AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment
Time Frame
Intraoperative
Title
Complications
Description
Total number of events during the procedure
Time Frame
intraoperative
Title
Complications
Description
Toral number of events related to the procedure in the follow-up (1 year)
Time Frame
12 months
Title
Need for Re-embolization
Description
Scheduled re-embolization due to incomplete occlusion
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel A De Gregorio, MD, PhD
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lozano Blesa University Hospital
City
Zaragoza
ZIP/Postal Code
50003
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
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