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Clinical Trials/NCT03057067
NCT03057067
Terminated
Not Applicable

Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

St. Olavs Hospital1 site in 1 country3 target enrollmentMay 19, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Pain
Sponsor
St. Olavs Hospital
Enrollment
3
Locations
1
Primary Endpoint
chronic pelvic pain
Status
Terminated
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 19, 2017
End Date
February 7, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Health related quality of life (HRQOL)(1 year)
  • Sexual function(1 year)

Study Sites (1)

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