Pelvic Congestive SyndromePhase 4ENDPCSNCT04358497
Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
A Phase 4 study testing Medtronic® Concerto® detachable coil system, sclerosis and Diosmin / Hesperidin in people with Pelvic Congestive Syndrome and Pelvic Varices, run by Hospital de Clínicas Dr. Manuel Quintela.
Trial summary
Compare the efficacy and safety of endovascular treatment with sandwich technique (controlled release coils and 2% polidocanol foam) associated with diosmin-hisperidine and ibuprofen medical treatment and only the best chronic medical treatment available diosmin-hisperidine and ibuprofen for 3 months, in women of… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Congestive Syndrome, Pelvic Varices, Venous Disease
- What is being tested?
- Medtronic® Concerto® detachable coil system, sclerosis and Diosmin / Hesperidin
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2022
- Phase
- Phase 4
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Active gynecological age
- Chronic pelvic pain diagnosed by gynecologist of at least 6 months of evolution.
- Transvaginal duplex ultrasound: presence of periuterine varicose veins defined by veins larger than 5mm in diameter with reflux greater than 0.5 seconds on Valsava maneuvers.
Who cannot join
- Presence of other causes of chronic pelvic pain: endometriosis, pelvic inflammatory disease, postoperative adhesions, uterine myoma, adenomyosis, ovarian tumors, polycystic ovary.
- Fibromyalgia
- BMI greater than 35
- Chronic kidney disease
- thrombophilia
- Alterationof coagulation.
- Allergy to iodinated contrast medium.
Trial locations and contacts
No sites are listed yet.
About this study
Compare the efficacy and safety of endovascular treatment with sandwich technique (controlled release coils and 2% polidocanol foam) associated with diosmin-hisperidine and ibuprofen medical treatment and only the best chronic medical treatment available diosmin-hisperidine and ibuprofen for 3 months, in women of active gynecological age carrying pelvic congestion syndrome in public assistance in Montevideo, Uruguay.
Read the detailed description
Pelvic congestion syndrome (PCS) is a recognized and frequent cause of Chronic Pelvic Pain (10% to 30%). It is defined as the presence of chronic symptoms, which may include pelvic pain, perineal heaviness, urinary urgency and postcoital pain, caused by reflux and / or obstruction of the gonadic and / or pelvic veins, and that may be associated with vulvar, perineal and lower limbs varicose veins.
There is no standard approach to managing PCS. According to expert recommendations, therapies should be individualized according to the patient's symptoms and needs.
Medical treatment options include progestagens, danazol, combined oral hormonal contraceptives, phlebotonics such as hisperidine-added diosmin, non-steroidal anti-inflammatory drugs and gonadotropin-releasing hormone (GnRH) agonists
Currently, the only accepted chronic medical treatment is the association of non-steroidal and phlebotonic anti-inflammatories, but they have shown a poor symptomatic benefit in reducing pain.
Surgical treatment has evolved over time mainly in the hands of laparoscopic techniques, currently the endovascular option is the most widely accepted for presenting excellent long-term results with abolition of pain in up to 90% at 2 years.
HYPOTHESIS
Endovascular treatment of pelvic congestion syndrome is better in terms of pain control and quality of life compared to drug treatment.
General objective
Compare the efficacy and safety of endovascular treatment with sandwich technique (controlled release coils and 2% polidocanol foam) associated with diosmin-hisperidine and ibuprofen medical treatment and only the best chronic medical treatment available diosmin-hisperidine and ibuprofen for 3 months, in women of active gynecological age carrying pelvic congestion syndrome in public assistance in Montevideo, Uruguay.
Specific objectives
- Compare pain in patients undergoing endovascular treatment with the best medical treatment.
- Evaluate the persistence of pelvic varices in patients undergoing endovascular treatment of SCP.
- Compare the Female Sexual Satisfaction Index in both groups.
- Conditions
- Pelvic Congestive Syndrome, Pelvic Varices, Venous Disease
- Being tested
- Medtronic® Concerto® detachable coil system, sclerosis, Diosmin / Hesperidin, Ibuprofen 400 mg
- Keywords
- pelvic congestion syndrome, sclerosis, coil embolization
- Medical subject headings
- Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic® Concerto® detachable coil systemDevice
Also called concerto detachable coil system
coil embolization of the reflux pathways
sclerosisProcedure or surgery
Also called Foam sclerosis with polidocanol 2%
Pelvic varices sclerosis with polidocanol foam
Diosmin / HesperidinDrug
Also called daflon
Best chronic medial treatment
Ibuprofen 400 mgDrug
Also called Nsaid
NSAID treatment
| Study group | Role | What they receive |
|---|---|---|
| Interventional treatment plus best chronic medical treatment | Experimental | Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months Receives: Device: Medtronic® Concerto® detachable coil system; Procedure: sclerosis; Drug: Diosmin / Hesperidin; Drug: Ibuprofen 400 mg |
| Best chronic medical treatment alone | Active comparator | Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months Receives: Drug: Diosmin / Hesperidin; Drug: Ibuprofen 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
Pain assessment 1-10 from no pain to severe
Measured: 30 days
visual analogue scale (VAS)
Pain assessment 1-10 from no pain to severe
Measured: 3 months
Lattinen index
chronic pain assessment 2-22 from low to high
Measured: 30 days
Lattinen index
chronic pain assessment 2-22 from low to high
Measured: 3 months
McGill Pain Questionnaire
subjective pain experience assessment
Measured: 30 days
McGill Pain Questionnaire
subjective pain experience assessment
Measured: 3 months
Secondary outcomes (6)
Female sexual function index
questionnaire that assesses different domains of sexual function. 0-48 from no sexual distress to high level of sexual distress
Measured: 30 days
Female sexual function index
questionnaire that assesses different domains of sexual function. . 0-48 from no sexual distress to high level of sexual distress
Measured: 3 months
varicose and reflux persistance by transabdominal duplex scan
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
Measured: 30 days
varicose and reflux persistance by transabdominal duplex scan
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
Measured: 3 months
varicose and reflux persistance by transvaginal duplex scan
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
Measured: 3 months
varicose persistance assesment by tomography
angiotomography: Varicose and conadic Patency
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestive SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blind randomized clinical trial designed to compare the efficacy and safety of endovascular treatment of Pelvic congestion syndrome.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clínicas Dr. Manuel Quintela
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Republic, Uruguay, Centro Cardiovascular Universitario, Centro Hospitalario Pereyra Rossell
- Responsible party
- Principal investigator, Eduardo Sebastian Sarutte Rosello, MD VS MSc, Hospital de Clínicas Dr. Manuel Quintela
- Investigators
- Sebastian Sarutte, VS, Principal investigator, Centro Cardiovascular Universitario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358497
- Sponsor's protocol ID
- TR001
- Acronym
- ENDPCS
- Status last verified
- Apr 2020
- First submitted
- 17 Jan 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data base for all variables will be available for researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
- ClinicalTrials.gov ID
- NCT04358497
- Acronym / sponsor ID
- ENDPCS / TR001
- Conditions
- Pelvic Congestive Syndrome, Pelvic Varices, Venous Disease
- Keywords
- pelvic congestion syndrome, sclerosis, coil embolization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital de Clínicas Dr. Manuel QuintelaUniversity, hospital or other
- Collaborators
- University of the Republic, Uruguay, Centro Cardiovascular Universitario, Centro Hospitalario Pereyra Rossell
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 24 Apr 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.
Compare the efficacy and safety of endovascular treatment with sandwich technique (controlled release coils and 2% polidocanol foam) associated with diosmin-hisperidine and ibuprofen medical treatment and only the best chronic medical treatment available diosmin-hisperidine and ibuprofen for 3 months, in women of active gynecological age carrying pelvic congestion syndrome in public assistance in Montevideo, Uruguay.
Detailed description
Pelvic congestion syndrome (PCS) is a recognized and frequent cause of Chronic Pelvic Pain (10% to 30%). It is defined as the presence of chronic symptoms, which may include pelvic pain, perineal heaviness, urinary urgency and postcoital pain, caused by reflux and / or obstruction of the gonadic and / or pelvic veins, and that may be associated with vulvar, perineal and lower limbs varicose veins.
There is no standard approach to managing PCS. According to expert recommendations, therapies should be individualized according to the patient's symptoms and needs.
Medical treatment options include progestagens, danazol, combined oral hormonal contraceptives, phlebotonics such as hisperidine-added diosmin, non-steroidal anti-inflammatory drugs and gonadotropin-releasing hormone (GnRH) agonists
Currently, the only accepted chronic medical treatment is the association of non-steroidal and phlebotonic anti-inflammatories, but they have shown a poor symptomatic benefit in reducing pain.
Surgical treatment has evolved over time mainly in the hands of laparoscopic techniques, currently the endovascular option is the most widely accepted for presenting excellent long-term results with abolition of pain in up to 90% at 2 years.
HYPOTHESIS
Endovascular treatment of pelvic congestion syndrome is better in terms of pain control and quality of life compared to drug treatment.
General objective
Compare the efficacy and safety of endovascular treatment with sandwich technique (controlled release coils and 2% polidocanol foam) associated with diosmin-hisperidine and ibuprofen medical treatment and only the best chronic medical treatment available diosmin-hisperidine and ibuprofen for 3 months, in women of active gynecological age carrying pelvic congestion syndrome in public assistance in Montevideo, Uruguay.
Specific objectives
- Compare pain in patients undergoing endovascular treatment with the best medical treatment.
- Evaluate the persistence of pelvic varices in patients undergoing endovascular treatment of SCP.
- Compare the Female Sexual Satisfaction Index in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Blind randomized clinical trial designed to compare the efficacy and safety of endovascular treatment of Pelvic congestion syndrome.
| Arm | Type | Receives |
|---|---|---|
| Interventional treatment plus best chronic medical treatment | Experimental | Device: Medtronic® Concerto® detachable coil system, Procedure: sclerosis, Drug: Diosmin / Hesperidin, Drug: Ibuprofen 400 mgSandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months |
| Best chronic medical treatment alone | Active comparator | Drug: Diosmin / Hesperidin, Drug: Ibuprofen 400 mgDiosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Active gynecological age
- Chronic pelvic pain diagnosed by gynecologist of at least 6 months of evolution.
- Transvaginal duplex ultrasound: presence of periuterine varicose veins defined by veins larger than 5mm in diameter with reflux greater than 0.5 seconds on Valsava maneuvers.
Key exclusion criteria (7 listed)
- Presence of other causes of chronic pelvic pain: endometriosis, pelvic inflammatory disease, postoperative adhesions, uterine myoma, adenomyosis, ovarian tumors, polycystic ovary.
- Fibromyalgia
- BMI greater than 35
- Chronic kidney disease
- thrombophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic® Concerto® detachable coil systemAlso: concerto detachable coil systemcoil embolization of the reflux pathways | Device | Interventional treatment plus best chronic medical treatment |
| sclerosisAlso: Foam sclerosis with polidocanol 2%Pelvic varices sclerosis with polidocanol foam | Procedure or surgery | Interventional treatment plus best chronic medical treatment |
| Diosmin / HesperidinAlso: daflonBest chronic medial treatment | Drug | Best chronic medical treatment alone, Interventional treatment plus best chronic medical treatment |
| Ibuprofen 400 mgAlso: NsaidNSAID treatment | Drug | Best chronic medical treatment alone, Interventional treatment plus best chronic medical treatment |
Primary outcome
visual analogue scale (VAS)
Time frame: 30 days
Pain assessment 1-10 from no pain to severe
visual analogue scale (VAS)
Time frame: 3 months
Pain assessment 1-10 from no pain to severe
Lattinen index
Time frame: 30 days
chronic pain assessment 2-22 from low to high
Lattinen index
Time frame: 3 months
chronic pain assessment 2-22 from low to high
McGill Pain Questionnaire
Time frame: 30 days
subjective pain experience assessment
McGill Pain Questionnaire
Time frame: 3 months
subjective pain experience assessment
6 secondary outcomes
Female sexual function index
Time frame: 30 days
Female sexual function index
Time frame: 3 months
varicose and reflux persistance by transabdominal duplex scan
Time frame: 30 days
varicose and reflux persistance by transabdominal duplex scan
Time frame: 3 months
varicose and reflux persistance by transvaginal duplex scan
Time frame: 3 months
varicose persistance assesment by tomography
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Yes. De-identified data base for all variables will be available for researchers
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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.
Sebastian Sarutte, VS principal investigator
Centro Cardiovascular Universitario
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medtronic® Concerto® detachable coil system, sclerosis and Diosmin / Hesperidin in people with Pelvic Congestive Syndrome and Pelvic Varices, run by Hospital de Clínicas Dr. Manuel Quintela.
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 7 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 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sebastian Sarutte, VS (+59899533449, ssarutte1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (VAS) (time frame: 30 days). The study lists 6 primary outcomes in all. 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 24 Apr 2020.