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Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04461860
Acronym
SCVPC
Enrollment
20
Registered
2020-07-08
Start date
2020-04-21
Completion date
2021-05-31
Last updated
2020-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Pain

Keywords

syndrome, pain, pelvic, vein, embolization

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).

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pelvic congestion pain reliefpre-embolization and 1 month post-gonadal vein embolizationTo 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

MeasureTime frameDescription
evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire surveypre-embolization and 1 month post-gonadal vein embolizationto 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 surveypre-embolization and 1 month post-gonadal vein embolizationto assess the impact of gonadal vein embolization on general symptoms of pelvic congestion syndrome through a self-reported questionnaire survey.

Countries

France

Contacts

Primary ContactPhilippe QUEHE
philippe.quehe@chu-brest.fr02 98 34 75 45

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026