Trial Outcomes & Findings for Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome (NCT NCT02796092)
NCT ID: NCT02796092
Last Updated: 2017-03-29
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
12 months
Results posted on
2017-03-29
Participant Flow
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.
Participant milestones
| Measure |
Fibered Platinum Coils
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
Vascular Plugs
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Baseline characteristics by cohort
| Measure |
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.00 years
STANDARD_DEVIATION 6.26 • n=5 Participants
|
44.34 years
STANDARD_DEVIATION 8.45 • n=7 Participants
|
42.67 years
STANDARD_DEVIATION 7.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Living children
|
1.86 Children
STANDARD_DEVIATION 0.96 • n=5 Participants
|
1.78 Children
STANDARD_DEVIATION 0.71 • n=7 Participants
|
1.82 Children
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Pre-treatment Visual Analogue Score
|
7.14 units on a scale
STANDARD_DEVIATION 1.55 • n=5 Participants
|
7.88 units on a scale
STANDARD_DEVIATION 1.01 • n=7 Participants
|
7.51 units on a scale
STANDARD_DEVIATION 1.36 • n=5 Participants
|
|
Pain in orthostatic position
YES
|
48 participants
n=5 Participants
|
50 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Pain in orthostatic position
NO
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Pain in supine position
YES
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Pain in supine position
NO
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Dyspareunia
YES
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Dyspareunia
NO
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Dysmenorrhea
YES
|
27 participants
n=5 Participants
|
35 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Dysmenorrhea
NO
|
23 participants
n=5 Participants
|
15 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Urinary urgency
YES
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Urinary urgency
NO
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
History of ovarian cystic disease
YES
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
History of ovarian cystic disease
NO
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
History of vaginal varicosities
YES
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
History of vaginal varicosities
NO
|
40 participants
n=5 Participants
|
42 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
History of vulvar varicosities
YES
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
History of vulvar varicosities
NO
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
History of lower limb varices
YES
|
45 participants
n=5 Participants
|
44 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
History of lower limb varices
NO
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
History of lower limb varices surgery
YES
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
History of lower limb varices surgery
NO
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Maximum right pelvic venous caliber
|
7.38 mm
STANDARD_DEVIATION 1.19 • n=5 Participants
|
7.36 mm
STANDARD_DEVIATION 1.22 • n=7 Participants
|
7.37 mm
STANDARD_DEVIATION 1.20 • n=5 Participants
|
|
Maximum left pelvic venous caliber
|
6.78 mm
STANDARD_DEVIATION 1.96 • n=5 Participants
|
6.66 mm
STANDARD_DEVIATION 1.55 • n=7 Participants
|
6.72 mm
STANDARD_DEVIATION 1.76 • n=5 Participants
|
|
Varicocele
YES
|
41 participants
n=5 Participants
|
45 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Varicocele
NO
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Ovarian vein reflux
YES
|
40 participants
n=5 Participants
|
35 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Ovarian vein reflux
NO
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Waveform change in Valsalva's maneuver
YES
|
25 participants
n=5 Participants
|
30 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Waveform change in Valsalva's maneuver
NO
|
25 participants
n=5 Participants
|
20 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Population presenting pre-treatment pain (more than 1 in VAS)
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)
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=49 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Change in Pain Scale
IMPROVEMENT
|
48 participants
|
47 participants
|
|
Change in Pain Scale
NO IMPROVEMENT
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Population presenting pre-treatment dyspareunia
Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Outcome measures
| Measure |
Vascular Plugs
n=27 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=27 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Improvement of Dyspareunia
IMPROVEMENT
|
21 participants
|
24 participants
|
|
Improvement of Dyspareunia
NO IMPROVEMENT
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Population presenting pre-treatment urinary urgency
Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Outcome measures
| Measure |
Vascular Plugs
n=6 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=7 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Improvement of Urinary Urgency
IMPROVEMENT
|
6 participants
|
6 participants
|
|
Improvement of Urinary Urgency
NO IMPROVEMENT
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Population presenting pre-treatment dysmenorrhea
Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Outcome measures
| Measure |
Vascular Plugs
n=35 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=27 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Improvement of Dysmenorrhea
IMPROVEMENT
|
31 participants
|
24 participants
|
|
Improvement of Dysmenorrhea
NO IMPROVEMENT
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 12 monthsOverall 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.
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Satisfaction With the Procedure
|
7.90 units on a scale
Standard Deviation 1.05
|
8.22 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: intraoperativeNumber of coils and number of vascular plugs used in each procedure
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Number of Devices Used
|
4.06 devices
Standard Deviation 0.31
|
18.16 devices
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: IntraoperativeCost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Cost of Treatment
|
4069.79 US Dollars
Standard Deviation 138.64
|
3295.05 US Dollars
Standard Deviation 240.08
|
SECONDARY outcome
Timeframe: IntraoperativeTotal time length of the procedure, from puncture to compression (in minutes)
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Total Intervention Duration
|
29.02 minutes
Standard Deviation 5.95
|
44.46 minutes
Standard Deviation 4.09
|
SECONDARY outcome
Timeframe: IntraoperativeTotal fluoroscopy time, recorded by the equipment (in minutes)
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Fluoroscopy Time
|
19.52 minutes
Standard Deviation 6.14
|
33.41 minutes
Standard Deviation 4.68
|
SECONDARY outcome
Timeframe: IntraoperativeDAP, dose area product of the intervention, (in mGy\*cm\^2), recorded by fluoroscopy equipment
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Procedure Radiation Dose (DAP)
|
189935.60 mGy*cm^2
Standard Deviation 180002.93
|
354573.00 mGy*cm^2
Standard Deviation 105047.76
|
SECONDARY outcome
Timeframe: IntraoperativeAK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Procedure Radiation Dose (AK)
|
320.66 mGy
Standard Deviation 134.33
|
947.99 mGy
Standard Deviation 248.45
|
SECONDARY outcome
Timeframe: intraoperativeTotal number of events during the procedure
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Complications
|
4 minor events
|
11 minor events
|
SECONDARY outcome
Timeframe: 12 monthsToral number of events related to the procedure in the follow-up (1 year)
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Complications
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: 12 monthsScheduled re-embolization due to incomplete occlusion
Outcome measures
| Measure |
Vascular Plugs
n=50 Participants
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
Fibered Platinum Coils
n=50 Participants
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
|---|---|---|
|
Need for Re-embolization
Re-embolized
|
2 participants
|
7 participants
|
|
Need for Re-embolization
No
|
48 participants
|
43 participants
|
Adverse Events
Fibered Platinum Coils
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Vascular Plugs
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fibered Platinum Coils
n=50 participants at risk
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils
|
Vascular Plugs
n=50 participants at risk
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs
|
|---|---|---|
|
Vascular disorders
Migration of implant or internal device
|
6.0%
3/50 • Number of events 3 • Intraoperative, 3, 6, and 12 months
|
2.0%
1/50 • Number of events 1 • Intraoperative, 3, 6, and 12 months
|
|
Musculoskeletal and connective tissue disorders
Hematoma of neck
|
4.0%
2/50 • Number of events 2 • Intraoperative, 3, 6, and 12 months
|
4.0%
2/50 • Number of events 2 • Intraoperative, 3, 6, and 12 months
|
|
Vascular disorders
Extravasation of blood
|
12.0%
6/50 • Number of events 6 • Intraoperative, 3, 6, and 12 months
|
4.0%
2/50 • Number of events 2 • Intraoperative, 3, 6, and 12 months
|
Additional Information
Prof. Alicia Laborda
GITMI (University of Zaragoza)
Phone: 0034 976 76 15 49
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place