Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization

Pelvic Pain Clinical Trial

— SCVPC  

Official title:

Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04461860
• Other study ID #: SCVPC (29BRC20.0089)
• Status: Recruiting
• Start date: April 21, 2020
• Est. completion date: May 2021

Study information

• Verified date: May 2020
• Source: University Hospital, Brest
• Contact: Philippe QUEHE
• Phone: 02 98 34 75 45
• Email: philippe.quehe[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Pain

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic congestion pain relief	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.	pre-embolization and 1 month post-gonadal vein embolization
Secondary	evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire survey	to assess the impact of gonadal vein embolization on specific symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.	pre-embolization and 1 month post-gonadal vein embolization
Secondary	evaluation of general pelvic syndrome symptoms using a self-reported questionnaire survey	to assess the impact of gonadal vein embolization on general symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.	pre-embolization and 1 month post-gonadal vein embolization