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Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057067
Recruitment Status : Terminated (difficulties recruiting)
First Posted : February 17, 2017
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:

Results of recent systematic reviews suggest favorable results of embolization for the treatment of Pelvic Congestion Syndrome (PCS) compared with pre-procedure symptoms for several outcomes, including pain reduction, overall patient satisfaction, and technical feasibility. Reported complication rates appears relatively low.

Pelvic vein embolization is a relatively new technology and the results may provide background for an evidence based decision to offer embolization of pelvic varicosities for women with PCS in Norway.


Condition or disease Intervention/treatment Phase
Pelvic Pain Varicose Veins Procedure: Embolization of pelvic vein varicosities Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital are eligible for initial assessment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
Actual Study Start Date : May 19, 2017
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : February 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pelvic vein embolization
female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital, Trondheim, Norway
Procedure: Embolization of pelvic vein varicosities
Embolization of pelvic vein varicosities




Primary Outcome Measures :
  1. chronic pelvic pain [ Time Frame: 3 months ]
    assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain

  2. chronic pelvic pain [ Time Frame: 6 months ]
    assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain

  3. chronic pelvic pain [ Time Frame: 1 year ]
    assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain


Secondary Outcome Measures :
  1. Health related quality of life (HRQOL) [ Time Frame: 3 months ]
    based on the SF-8 and mental health measurements based on the 5-mental health inventory

  2. Health related quality of life (HRQOL) [ Time Frame: 6 months ]
    based on the SF-8 and mental health measurements based on the 5-mental health inventory

  3. Health related quality of life (HRQOL) [ Time Frame: 1 year ]
    based on the SF-8 and mental health measurements based on the 5-mental health inventory

  4. Sexual function [ Time Frame: 3 months ]
    assessed with a short screening tool for sexual dysfunction, containing 4 questions plus 6 sub-questions (Hatzichristou D et al. J Sex Med 2004) - Norwegian translation (non-validated)

  5. Sexual function [ Time Frame: 6 months ]
    assessed with a short screening tool for sexual dysfunction, containing 4 questions plus 6 sub-questions (Hatzichristou D et al. J Sex Med 2004) - Norwegian translation (non-validated)

  6. Sexual function [ Time Frame: 1 year ]
    assessed with a short screening tool for sexual dysfunction, containing 4 questions plus 6 sub-questions (Hatzichristou D et al. J Sex Med 2004) - Norwegian translation (non-validated)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pelvic pain (lasting for more than 6 months)
  • Symptoms of PCS - deterioration of pain when standing and improvement in supine position (with or without dyspareunia or dysmenorrhea).
  • Confirmed pelvic varicosities by magnetic resonance examination.
  • Signed, written and informed consent

Exclusion Criteria:

  • Inability to communicate in Norwegian
  • Known endometriosis
  • Uterine myoma, uterine anomalies, or cancer
  • Postmenopausal
  • not having been pregnant

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): NCT03057067


Locations
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Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Investigators
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Principal Investigator: Risa AM Lonnee-Hoffmann, md phd St. Olavs Hospital
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03057067    
Other Study ID Numbers: 2016/1881
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Embolization, Therapeutic
Pelvis
Additional relevant MeSH terms:
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Varicose Veins
Pelvic Pain
Pain
Neurologic Manifestations
Vascular Diseases
Cardiovascular Diseases