Clinical trial NCT04461860: Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization
Official title: Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Pain
Keywords: syndrome
pain
pelvic
vein
embolization
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women \> 18 years old with at least 1 previous pregnancy and delivery

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pelvic congestion pain relief
timeFrame: pre-embolization and 1 month post-gonadal vein embolization
Secondary outcomes:
measure: evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire survey
timeFrame: pre-embolization and 1 month post-gonadal vein embolization
measure: evaluation of general pelvic syndrome symptoms using a self-reported questionnaire survey
timeFrame: pre-embolization and 1 month post-gonadal vein embolization
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: