Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization

• Conditions: Pelvic Pain

• Registration Number: NCT04461860
• Lead Sponsor: University Hospital, Brest

Brief Summary

Summary:

Main Objective: to evaluate the efficacy of pelvic gonadal vein embolization with coils in treatment of pelvic congestion syndrome Methods: retrospective study included 25 patients in the University hospital of Brest.

The Primary Outcome Measure: To evaluate (to measure) pain relief using visual analogous scale (VAS) before and after gonadal vein embolization for pelvic congestion syndrome The Secondary Outcome Measures were to assess the impact of the treatment on specific and general symptoms through a survey.

Detailed Description

A retrospective, non-invasive monocentric study of our Hospital 10-year registry (including data on MRI angiography and Vascular Doppler Ultrasound) of patients who have already undergone coil embolization of pelvic gonadal vein in treatment of pelvic congestion syndrome. These patients will be contacted by phone to participate in the study. An information letter will be handed out and the study protocol will be explained to the patients. After obtaining their written consent, they will be asked to fill out the study's validated questionnaire at home and return it to us through pre-paid regular mail. A face to face interview with the patient will be scheduled to assess the correlation between patient's clinical symptoms and survey results. There will be no change in patient's routine follow-up care.

All physician investigators of the study are experts in their field of medicine (e.g. interventional MRI angiography, vascular disease).

Study Timeline

• Study Start: 2020-04-21
• Status Verified: 2020-05
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Clinical symptoms of pelvic congestion syndrome documented by Vascular Doppler ultrasound and vascular dynamic MRI
• Failed medical treatment.
• > 18 years < 60 years old

Exclusion Criteria

• < 18 years old
• Under legal guardian
• Asymptomatic pelvic congestion syndrome
• Psychiatric disorder
• Endometriosis.
• Chronic pelvic disease
• Pregnancy
• Neoplasia
• Acute intermittent porphyria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pelvic congestion pain relief	pre-embolization and 1 month post-gonadal vein embolization	To evaluate (to measure) pain relief using visual analogous scale before and after gonadal vein embolization for pelvic congestion syndrome. A high score means a worse outcome.

Secondary Outcome Measures

Name	Time	Method
evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire survey	pre-embolization and 1 month post-gonadal vein embolization	to assess the impact of gonadal vein embolization on specific symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.
evaluation of general pelvic syndrome symptoms using a self-reported questionnaire survey	pre-embolization and 1 month post-gonadal vein embolization	to assess the impact of gonadal vein embolization on general symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France