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Trial record 26 of 547 for:    varicose veins

Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

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ClinicalTrials.gov Identifier: NCT03057067
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : June 7, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

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


Contacts
Contact: Risa AM Lonnee-Hoffmann, md phd +47 73597570 risa.lonnee-hoffmann@stolav.no
Contact: Cecilie Therese Hagemann, phd +47 72573825 cecilie.hagemann@ntnu.no

Locations
Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Risa AM Lonnee-Hoffmann       risa.lonnee-hoffmann@stolav.no   
Sponsors and Collaborators
St. Olavs Hospital
Investigators
Principal Investigator: Risa AM Lonnee-Hoffmann, md phd St. Olavs Hospital

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03057067     History of Changes
Other Study ID Numbers: 2016/1881
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Pelvic Pain
Varicose Veins
Pain
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases