Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

Pelvic Pain Clinical Trial

Official title:

Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03057067
• Other study ID #: 2016/1881
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pelvic Pain
• Varicose Veins

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