Pelvic PainSCVPCNCT04461860
Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization
An observational study of Pelvic Pain, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pelvic Pain
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2020to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: women > 18 years old with at least 1 previous pregnancy and delivery
Who may be able to join
- Clinical symptoms of pelvic congestion syndrome documented by Vascular Doppler ultrasound and vascular dynamic MRI
- Failed medical treatment.
- > 18 years < 60 years old
Who cannot join
- < 18 years old
- Under legal guardian
- Asymptomatic pelvic congestion syndrome
- Psychiatric disorder
- Endometriosis.
- Chronic pelvic disease
Show all 9Show fewer
- Pregnancy
- Neoplasia
- Acute intermittent porphyria
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Philippe QUEHE, philippe.quehe@chu-brest.fr
About this study
Official title: 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.
Read the 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).
- Conditions
- Pelvic Pain
- Keywords
- syndrome, pain, pelvic, vein, embolization
- Medical subject headings
- Pelvic Pain, Syndrome, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-embolization and 1 month post-gonadal vein embolization
Secondary outcomes (2)
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.
Measured: 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.
Measured: pre-embolization and 1 month post-gonadal vein embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start21 Apr 2020
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461860
- Sponsor's protocol ID
- SCVPC (29BRC20.0089)
- Acronym
- SCVPC
- Status last verified
- May 2020
- First submitted
- 19 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)
- ClinicalTrials.gov ID
- NCT04461860
- Acronym / sponsor ID
- SCVPC / SCVPC (29BRC20.0089)
- Conditions
- Pelvic Pain
- Keywords
- syndrome, pain, pelvic, vein, embolization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women > 18 years old with at least 1 previous pregnancy and delivery
Key inclusion criteria (3 listed)
- Clinical symptoms of pelvic congestion syndrome documented by Vascular Doppler ultrasound and vascular dynamic MRI
- Failed medical treatment.
- > 18 years < 60 years old
Key exclusion criteria (9 listed)
- < 18 years old
- Under legal guardian
- Asymptomatic pelvic congestion syndrome
- Psychiatric disorder
- Endometriosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pelvic congestion pain relief
Time frame: pre-embolization and 1 month post-gonadal vein embolization
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.
2 secondary outcomes
evaluation of specific pelvic syndrome symptoms using a self-reported questionnaire survey
Time frame: pre-embolization and 1 month post-gonadal vein embolization
evaluation of general pelvic syndrome symptoms using a self-reported questionnaire survey
Time frame: pre-embolization and 1 month post-gonadal vein embolization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Pain, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe QUEHE (02 98 34 75 45, philippe.quehe@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic congestion pain relief (time frame: pre-embolization and 1 month post-gonadal vein embolization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.