Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

Conditions
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Pelvic Pain, Varicose Veins

Intervention / Treatment
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* Procedure: Embolization of pelvic vein varicosities


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital are eligible for initial assessment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pelvic vein embolization<br>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<br>* Embolization of pelvic vein varicosities<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embolization, Therapeutic, Pelvis