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Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

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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

Tracking Information
First Submitted Date  ICMJE February 15, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE May 19, 2017
Actual Primary Completion Date February 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • chronic pelvic pain [ Time Frame: 3 months ]
    assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
  • chronic pelvic pain [ Time Frame: 6 months ]
    assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
  • chronic pelvic pain [ Time Frame: 1 year ]
    assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
Official Title  ICMJE Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Pelvic Pain
  • Varicose Veins
Intervention  ICMJE Procedure: Embolization of pelvic vein varicosities
Embolization of pelvic vein varicosities
Study Arms  ICMJE 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
Intervention: Procedure: Embolization of pelvic vein varicosities
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 7, 2019)
3
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2017)
30
Actual Study Completion Date  ICMJE February 7, 2019
Actual Primary Completion Date February 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03057067
Other Study ID Numbers  ICMJE 2016/1881
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party St. Olavs Hospital
Study Sponsor  ICMJE St. Olavs Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Risa AM Lonnee-Hoffmann, md phd St. Olavs Hospital
PRS Account St. Olavs Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP