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Completed

NCT Number: NCT02796092

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

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.

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Key information

Conditions

Pelvic Congestion Syndrome

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lozano Blesa University Hospital

Zaragoza, 50003, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibered platinum coils

Device

Other names: Nester coils

Vascular plugs

Device

Other names: Amplatzer vascular plugs

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Group of Research in Minimally Invasive Techniques

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 10, 2016
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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