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Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome

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ClinicalTrials.gov Identifier: NCT02796092
Recruitment Status : Completed
First Posted : June 10, 2016
Results First Posted : October 26, 2016
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Group of Research in Minimally Invasive Techniques

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pelvic Congestion Syndrome Device: Fibered platinum coils Device: Vascular plugs Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Study Start Date : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2016
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fibered platinum coils
Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)
 Device: Fibered platinum coils
Other Name: Nester coils
Experimental: Vascular plugs
Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)
 Device: Vascular plugs
Other Name: Amplatzer vascular plugs


Outcome Measures
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Primary Outcome Measures :
  1. Change in Pain Scale [ Time Frame: 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 Outcome Measures :
  1. Improvement of Dyspareunia [ Time Frame: 12 months ]
    Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)

  2. Improvement of Urinary Urgency [ Time Frame: 12 months ]
    Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)

  3. Improvement of Dysmenorrhea [ Time Frame: 12 months ]
    Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)

  4. Satisfaction With the Procedure [ Time Frame: 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.


  5. Number of Devices Used [ Time Frame: intraoperative ]
    Number of coils and number of vascular plugs used in each procedure

  6. Cost of Treatment [ Time Frame: 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.

  7. Total Intervention Duration [ Time Frame: Intraoperative ]
    Total time length of the procedure, from puncture to compression (in minutes)

  8. Fluoroscopy Time [ Time Frame: Intraoperative ]
    Total fluoroscopy time, recorded by the equipment (in minutes)

  9. Procedure Radiation Dose (DAP) [ Time Frame: Intraoperative ]
    DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment

  10. Procedure Radiation Dose (AK) [ Time Frame: Intraoperative ]
    AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment

  11. Complications [ Time Frame: intraoperative ]
    Total number of events during the procedure

  12. Complications [ Time Frame: 12 months ]
    Toral number of events related to the procedure in the follow-up (1 year)

  13. Need for Re-embolization [ Time Frame: 12 months ]
    Scheduled re-embolization due to incomplete occlusion


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796092


Locations
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Spain
Lozano Blesa University Hospital
Zaragoza, Spain, 50003
Sponsors and Collaborators
Group of Research in Minimally Invasive Techniques
Investigators
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Principal Investigator: Miguel A De Gregorio, MD, PhD Universidad de Zaragoza
More Information
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Responsible Party: Group of Research in Minimally Invasive Techniques
ClinicalTrials.gov Identifier: NCT02796092    
Other Study ID Numbers: GTM-01
First Posted: June 10, 2016    Key Record Dates
Results First Posted: October 26, 2016
Last Update Posted: March 29, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Group of Research in Minimally Invasive Techniques:
Pelvic Congestion Syndrome
Pelvic Venous Insufficiency
Chronic pelvic pain
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes