Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

Not Applicable

Terminated

• Conditions: Varicose Veins; Pelvic Pain
• Interventions: Procedure: Embolization of pelvic vein varicosities

• Registration Number: NCT03057067
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-17
• Study Start: 2017-05-19
• Status Verified: 2019-02
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pelvic vein embolization	Embolization of pelvic vein varicosities	female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital, Trondheim, Norway

Primary Outcome Measures

Name	Time	Method
chronic pelvic pain	1 year	assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain

Secondary Outcome Measures

Name	Time	Method
Health related quality of life (HRQOL)	1 year	based on the SF-8 and mental health measurements based on the 5-mental health inventory
Sexual function	1 year	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)

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway