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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03057067
Other study ID # 2016/1881
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 19, 2017
Est. completion date February 7, 2019

Study information

Verified date February 2019
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Embolization of pelvic vein varicosities
Embolization of pelvic vein varicosities

Locations

Country Name City State
Norway St Olavs Hospital Trondheim

Sponsors (1)

Lead Sponsor Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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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