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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03057067 |
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Date of registration:
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15/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
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Scientific title:
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Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome |
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Date of first enrolment:
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May 19, 2017 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03057067 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Risa AM Lonnee-Hoffmann, md phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Olavs Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Varicose Veins
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Pelvic Pain
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Intervention(s)
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Procedure: Embolization of pelvic vein varicosities
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Primary Outcome(s)
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chronic pelvic pain
[Time Frame: 3 months]
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chronic pelvic pain
[Time Frame: 1 year]
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chronic pelvic pain
[Time Frame: 6 months]
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Secondary Outcome(s)
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Sexual function
[Time Frame: 6 months]
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Health related quality of life (HRQOL)
[Time Frame: 1 year]
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Sexual function
[Time Frame: 3 months]
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Health related quality of life (HRQOL)
[Time Frame: 3 months]
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Sexual function
[Time Frame: 1 year]
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Health related quality of life (HRQOL)
[Time Frame: 6 months]
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Secondary ID(s)
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2016/1881
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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