Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

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.

Study Overview

• Status: Terminated
• Conditions: Varicose Veins; Pelvic Pain
• Intervention / Treatment: Procedure: Embolization of pelvic vein varicosities

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pelvic vein embolization; 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	Procedure: Embolization of pelvic vein varicosities; Embolization of pelvic vein varicosities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chronic pelvic pain	assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain	3 months
chronic pelvic pain	assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain	6 months
chronic pelvic pain	assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life (HRQOL)	based on the SF-8 and mental health measurements based on the 5-mental health inventory	3 months
Health related quality of life (HRQOL)	based on the SF-8 and mental health measurements based on the 5-mental health inventory	6 months
Health related quality of life (HRQOL)	based on the SF-8 and mental health measurements based on the 5-mental health inventory	1 year
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
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
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

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Investigators: Principal Investigator: Risa AM Lonnee-Hoffmann, md phd, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2017
• Primary Completion (Actual): February 7, 2019
• Study Completion (Actual): February 7, 2019

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pelvis; Embolization, Therapeutic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Varicose Veins; Pelvic Pain
• Other Study ID Numbers: 2016/1881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No