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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Pain

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Philippe QUEHE; Phone Number: 02 98 34 75 45; Email: philippe.quehe@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Philippe QUEHE; Email: philippe.quehe@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women > 18 years old with at least 1 previous pregnancy and delivery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: pain; embolization; pelvic; syndrome; vein
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: SCVPC (29BRC20.0089)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be available beginning one year and ending five years following the end of the study
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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