Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization
SCVPC
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2020
CompletedFirst Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
July 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedJuly 8, 2020
May 1, 2020
1 year
June 19, 2020
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
evaluation of specific pelvic syndrome symptoms using 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
pre-embolization and 1 month post-gonadal vein embolization
Eligibility Criteria
women \> 18 years old with at least 1 previous pregnancy and delivery
You may qualify if:
- Clinical symptoms of pelvic congestion syndrome documented by Vascular Doppler ultrasound and vascular dynamic MRI
- Failed medical treatment.
- \> 18 years \< 60 years old
You may not qualify if:
- \< 18 years old
- Under legal guardian
- Asymptomatic pelvic congestion syndrome
- Psychiatric disorder
- Endometriosis.
- Chronic pelvic disease
- Pregnancy
- Neoplasia
- Acute intermittent porphyria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Brest
Brest, 29609, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2020
First Posted
July 8, 2020
Study Start
April 21, 2020
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
July 8, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning one year and ending five years following the end of the study
- 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.