Pelvic Pain Clinical Trial
Official title:
Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
Verified date | February 2019 |
Source | St. Olavs Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | February 7, 2019 |
Est. primary completion date | February 7, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | St Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
St. Olavs Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | chronic pelvic pain | assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain | 3 months | |
Primary | chronic pelvic pain | assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain | 6 months | |
Primary | chronic pelvic pain | assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain | 1 year | |
Secondary | Health related quality of life (HRQOL) | based on the SF-8 and mental health measurements based on the 5-mental health inventory | 3 months | |
Secondary | Health related quality of life (HRQOL) | based on the SF-8 and mental health measurements based on the 5-mental health inventory | 6 months | |
Secondary | Health related quality of life (HRQOL) | based on the SF-8 and mental health measurements based on the 5-mental health inventory | 1 year | |
Secondary | Sexual function | 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) | 3 months | |
Secondary | Sexual function | 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 months | |
Secondary | Sexual function | 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) | 1 year |
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