Pelvic Congestion Syndrome
Conditions
Keywords
Pelvic Congestion Syndrome, Pelvic Venous Insufficiency, Chronic pelvic pain
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).
Interventions
DEVICEFibered platinum coils
DEVICEVascular plugs
Sponsors
Group of Research in Minimally Invasive Techniques
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scale | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Urinary Urgency | 12 months | Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) |
| Improvement of Dysmenorrhea | 12 months | Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) |
| Satisfaction With the Procedure | 12 months | 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 | intraoperative | Number of coils and number of vascular plugs used in each procedure |
| Cost of Treatment | Intraoperative | 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. |
| Improvement of Dyspareunia | 12 months | Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO) |
| Fluoroscopy Time | Intraoperative | Total fluoroscopy time, recorded by the equipment (in minutes) |
| Procedure Radiation Dose (DAP) | Intraoperative | DAP, dose area product of the intervention, (in mGy\*cm\^2), recorded by fluoroscopy equipment |
| Procedure Radiation Dose (AK) | Intraoperative | AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment |
| Complications | intraoperative | Total number of events during the procedure |
| Need for Re-embolization | 12 months | Scheduled re-embolization due to incomplete occlusion |
| Total Intervention Duration | Intraoperative | Total time length of the procedure, from puncture to compression (in minutes) |
Countries
Spain
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Fibered Platinum Coils Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
Fibered platinum coils | 50 |
| Vascular Plugs Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
Vascular plugs | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Fibered Platinum Coils | Total | Vascular Plugs |
|---|---|---|---|
| Age, Continuous | 41.00 years STANDARD_DEVIATION 6.26 | 42.67 years STANDARD_DEVIATION 7.59 | 44.34 years STANDARD_DEVIATION 8.45 |
| Dysmenorrhea NO | 23 participants | 38 participants | 15 participants |
| Dysmenorrhea YES | 27 participants | 62 participants | 35 participants |
| Dyspareunia NO | 23 participants | 46 participants | 23 participants |
| Dyspareunia YES | 27 participants | 54 participants | 27 participants |
| History of lower limb varices NO | 5 participants | 11 participants | 6 participants |
| History of lower limb varices YES | 45 participants | 89 participants | 44 participants |
| History of lower limb varices surgery NO | 40 participants | 80 participants | 40 participants |
| History of lower limb varices surgery YES | 10 participants | 20 participants | 10 participants |
| History of ovarian cystic disease NO | 28 participants | 57 participants | 29 participants |
| History of ovarian cystic disease YES | 22 participants | 43 participants | 21 participants |
| History of vaginal varicosities NO | 40 participants | 82 participants | 42 participants |
| History of vaginal varicosities YES | 10 participants | 18 participants | 8 participants |
| History of vulvar varicosities NO | 32 participants | 63 participants | 31 participants |
| History of vulvar varicosities YES | 18 participants | 37 participants | 19 participants |
| Living children | 1.86 Children STANDARD_DEVIATION 0.96 | 1.82 Children STANDARD_DEVIATION 0.8 | 1.78 Children STANDARD_DEVIATION 0.71 |
| Maximum left pelvic venous caliber | 6.78 mm STANDARD_DEVIATION 1.96 | 6.72 mm STANDARD_DEVIATION 1.76 | 6.66 mm STANDARD_DEVIATION 1.55 |
| Maximum right pelvic venous caliber | 7.38 mm STANDARD_DEVIATION 1.19 | 7.37 mm STANDARD_DEVIATION 1.2 | 7.36 mm STANDARD_DEVIATION 1.22 |
| Ovarian vein reflux NO | 10 participants | 25 participants | 15 participants |
| Ovarian vein reflux YES | 40 participants | 75 participants | 35 participants |
| Pain in orthostatic position NO | 2 participants | 2 participants | 0 participants |
| Pain in orthostatic position YES | 48 participants | 98 participants | 50 participants |
| Pain in supine position NO | 43 participants | 87 participants | 44 participants |
| Pain in supine position YES | 7 participants | 13 participants | 6 participants |
| Pre-treatment Visual Analogue Score | 7.14 units on a scale STANDARD_DEVIATION 1.55 | 7.51 units on a scale STANDARD_DEVIATION 1.36 | 7.88 units on a scale STANDARD_DEVIATION 1.01 |
| Sex: Female, Male Female | 50 Participants | 100 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Urinary urgency NO | 43 participants | 87 participants | 44 participants |
| Urinary urgency YES | 7 participants | 13 participants | 6 participants |
| Varicocele NO | 9 participants | 14 participants | 5 participants |
| Varicocele YES | 41 participants | 86 participants | 45 participants |
| Waveform change in Valsalva's maneuver NO | 25 participants | 45 participants | 20 participants |
| Waveform change in Valsalva's maneuver YES | 25 participants | 55 participants | 30 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 50 | 5 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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)
Time frame: 12 months
Population: Population presenting pre-treatment pain (more than 1 in VAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibered Platinum Coils | Change in Pain Scale | IMPROVEMENT | 47 participants |
| Fibered Platinum Coils | Change in Pain Scale | NO IMPROVEMENT | 2 participants |
| Vascular Plugs | Change in Pain Scale | IMPROVEMENT | 48 participants |
| Vascular Plugs | Change in Pain Scale | NO IMPROVEMENT | 2 participants |
Comparison: Assuming that both methods were equally effective, we did not use this primary outcome to calculate sample size. It was determined using our own retrospective data of patients from the year 2013, comparing the means of the procedure total time with both methods (41.20±4.66 vs 34.99±4.43 minutes). Ten patients in each group were considered enough to detect the above-mentioned differences with a α-error of 0.05 and 80% power, using a two-sided test.p-value: >0.999Fisher Exact
Secondary
Complications
Total number of events during the procedure
Time frame: intraoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibered Platinum Coils | Complications | 11 minor events |
| Vascular Plugs | Complications | 4 minor events |
p-value: 0.0499Chi-squared
Secondary
Complications
Toral number of events related to the procedure in the follow-up (1 year)
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fibered Platinum Coils | Complications | 0 events |
| Vascular Plugs | Complications | 0 events |
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.
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibered Platinum Coils | Cost of Treatment | 3295.05 US Dollars | Standard Deviation 240.08 |
| Vascular Plugs | Cost of Treatment | 4069.79 US Dollars | Standard Deviation 138.64 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Fluoroscopy Time
Total fluoroscopy time, recorded by the equipment (in minutes)
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibered Platinum Coils | Fluoroscopy Time | 33.41 minutes | Standard Deviation 4.68 |
| Vascular Plugs | Fluoroscopy Time | 19.52 minutes | Standard Deviation 6.14 |
p-value: <0.001t-test, 2 sided
Secondary
Improvement of Dysmenorrhea
Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Time frame: 12 months
Population: Population presenting pre-treatment dysmenorrhea
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibered Platinum Coils | Improvement of Dysmenorrhea | IMPROVEMENT | 24 participants |
| Fibered Platinum Coils | Improvement of Dysmenorrhea | NO IMPROVEMENT | 3 participants |
| Vascular Plugs | Improvement of Dysmenorrhea | IMPROVEMENT | 31 participants |
| Vascular Plugs | Improvement of Dysmenorrhea | NO IMPROVEMENT | 4 participants |
p-value: >0.999Fisher Exact
Secondary
Improvement of Dyspareunia
Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)
Time frame: 12 months
Population: Population presenting pre-treatment dyspareunia
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibered Platinum Coils | Improvement of Dyspareunia | NO IMPROVEMENT | 3 participants |
| Fibered Platinum Coils | Improvement of Dyspareunia | IMPROVEMENT | 24 participants |
| Vascular Plugs | Improvement of Dyspareunia | NO IMPROVEMENT | 6 participants |
| Vascular Plugs | Improvement of Dyspareunia | IMPROVEMENT | 21 participants |
p-value: 0.3Fisher Exact
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)
Time frame: 12 months
Population: Population presenting pre-treatment urinary urgency
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibered Platinum Coils | Improvement of Urinary Urgency | IMPROVEMENT | 6 participants |
| Fibered Platinum Coils | Improvement of Urinary Urgency | NO IMPROVEMENT | 1 participants |
| Vascular Plugs | Improvement of Urinary Urgency | IMPROVEMENT | 6 participants |
| Vascular Plugs | Improvement of Urinary Urgency | NO IMPROVEMENT | 0 participants |
p-value: >0.999Fisher Exact
Secondary
Need for Re-embolization
Scheduled re-embolization due to incomplete occlusion
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibered Platinum Coils | Need for Re-embolization | Re-embolized | 7 participants |
| Fibered Platinum Coils | Need for Re-embolization | No | 43 participants |
| Vascular Plugs | Need for Re-embolization | Re-embolized | 2 participants |
| Vascular Plugs | Need for Re-embolization | No | 48 participants |
p-value: 0.095Fisher Exact
Secondary
Number of Devices Used
Number of coils and number of vascular plugs used in each procedure
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibered Platinum Coils | Number of Devices Used | 18.16 devices | Standard Deviation 1.33 |
| Vascular Plugs | Number of Devices Used | 4.06 devices | Standard Deviation 0.31 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Procedure Radiation Dose (AK)
AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibered Platinum Coils | Procedure Radiation Dose (AK) | 947.99 mGy | Standard Deviation 248.45 |
| Vascular Plugs | Procedure Radiation Dose (AK) | 320.66 mGy | Standard Deviation 134.33 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Procedure Radiation Dose (DAP)
DAP, dose area product of the intervention, (in mGy\*cm\^2), recorded by fluoroscopy equipment
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibered Platinum Coils | Procedure Radiation Dose (DAP) | 354573.00 mGy*cm^2 | Standard Deviation 105047.76 |
| Vascular Plugs | Procedure Radiation Dose (DAP) | 189935.60 mGy*cm^2 | Standard Deviation 180002.93 |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibered Platinum Coils | Satisfaction With the Procedure | 8.22 units on a scale | Standard Deviation 1.04 |
| Vascular Plugs | Satisfaction With the Procedure | 7.90 units on a scale | Standard Deviation 1.05 |
p-value: 0.061Wilcoxon (Mann-Whitney)
Secondary
Total Intervention Duration
Total time length of the procedure, from puncture to compression (in minutes)
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibered Platinum Coils | Total Intervention Duration | 44.46 minutes | Standard Deviation 4.09 |
| Vascular Plugs | Total Intervention Duration | 29.02 minutes | Standard Deviation 5.95 |
p-value: <0.001t-test, 2 sided