Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome (ENDPCS)
Primary Purpose
Pelvic Congestive Syndrome, Pelvic Varices, Venous Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Medtronic® Concerto® detachable coil system
sclerosis
Diosmin / Hesperidin
Ibuprofen 400 mg
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Congestive Syndrome focused on measuring pelvic congestion syndrome, sclerosis, coil embolization
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interventional treatment plus best chronic medical treatment
Best chronic medical treatment alone
Arm Description
Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
Outcomes
Primary Outcome Measures
visual analogue scale (VAS)
Pain assessment 1-10 from no pain to severe
visual analogue scale (VAS)
Pain assessment 1-10 from no pain to severe
Lattinen index
chronic pain assessment 2-22 from low to high
Lattinen index
chronic pain assessment 2-22 from low to high
McGill Pain Questionnaire
subjective pain experience assessment
McGill Pain Questionnaire
subjective pain experience assessment
Secondary Outcome Measures
Female sexual function index
questionnaire that assesses different domains of sexual function. 0-48 from no sexual distress to high level of sexual distress
Female sexual function index
questionnaire that assesses different domains of sexual function. . 0-48 from no sexual distress to high level of sexual distress
varicose and reflux persistance by transabdominal duplex scan
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
varicose and reflux persistance by transabdominal duplex scan
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
varicose and reflux persistance by transvaginal duplex scan
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
varicose persistance assesment by tomography
angiotomography: Varicose and conadic Patency
Full Information
NCT ID
NCT04358497
First Posted
January 17, 2020
Last Updated
April 20, 2020
Sponsor
Hospital de Clínicas Dr. Manuel Quintela
Collaborators
University of the Republic, Uruguay, Centro Cardiovascular Universitario, Centro Hospitalario Pereyra Rossell
1. Study Identification
Unique Protocol Identification Number
NCT04358497
Brief Title
Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
Acronym
ENDPCS
Official Title
Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clínicas Dr. Manuel Quintela
Collaborators
University of the Republic, Uruguay, Centro Cardiovascular Universitario, Centro Hospitalario Pereyra Rossell
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Congestive Syndrome, Pelvic Varices, Venous Disease
Keywords
pelvic congestion syndrome, sclerosis, coil embolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Blind randomized clinical trial designed to compare the efficacy and safety of endovascular treatment of Pelvic congestion syndrome.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Phlebography will be performed to both groups. On the experimental group, the treatment of the pelvic congestion will be performed, while the procedure will be stopped on the control group. Neither the patient or the reference gynecologist will be informed if the treatment took place.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional treatment plus best chronic medical treatment
Arm Type
Experimental
Arm Description
Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
Arm Title
Best chronic medical treatment alone
Arm Type
Active Comparator
Arm Description
Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
Intervention Type
Device
Intervention Name(s)
Medtronic® Concerto® detachable coil system
Other Intervention Name(s)
concerto detachable coil system
Intervention Description
coil embolization of the reflux pathways
Intervention Type
Procedure
Intervention Name(s)
sclerosis
Other Intervention Name(s)
Foam sclerosis with polidocanol 2%
Intervention Description
Pelvic varices sclerosis with polidocanol foam
Intervention Type
Drug
Intervention Name(s)
Diosmin / Hesperidin
Other Intervention Name(s)
daflon
Intervention Description
Best chronic medial treatment
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Other Intervention Name(s)
Nsaid
Intervention Description
NSAID treatment
Primary Outcome Measure Information:
Title
visual analogue scale (VAS)
Description
Pain assessment 1-10 from no pain to severe
Time Frame
30 days
Title
visual analogue scale (VAS)
Description
Pain assessment 1-10 from no pain to severe
Time Frame
3 months
Title
Lattinen index
Description
chronic pain assessment 2-22 from low to high
Time Frame
30 days
Title
Lattinen index
Description
chronic pain assessment 2-22 from low to high
Time Frame
3 months
Title
McGill Pain Questionnaire
Description
subjective pain experience assessment
Time Frame
30 days
Title
McGill Pain Questionnaire
Description
subjective pain experience assessment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Female sexual function index
Description
questionnaire that assesses different domains of sexual function. 0-48 from no sexual distress to high level of sexual distress
Time Frame
30 days
Title
Female sexual function index
Description
questionnaire that assesses different domains of sexual function. . 0-48 from no sexual distress to high level of sexual distress
Time Frame
3 months
Title
varicose and reflux persistance by transabdominal duplex scan
Description
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
Time Frame
30 days
Title
varicose and reflux persistance by transabdominal duplex scan
Description
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
Time Frame
3 months
Title
varicose and reflux persistance by transvaginal duplex scan
Description
transabdominal duplex scan: varicose permeability, prescience of gonadic or iliac reflux
Time Frame
3 months
Title
varicose persistance assesment by tomography
Description
angiotomography: Varicose and conadic Patency
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Deep venous thrombosis by duplex ultrasound
Description
Deep venous thrombosis of the iliac or femoral axis will be reported
Time Frame
30 days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Sarutte, VS
Phone
+59899533449
Email
ssarutte1@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mauricio Volpi, VS
Phone
+59899605556
Email
mavolpi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Sarutte, VS
Organizational Affiliation
Centro Cardiovascular Universitario
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data base for all variables will be available for researchers
IPD Sharing Time Frame
From April 2022 to april 2024
IPD Sharing Access Criteria
Data will be shared on request, after signing a discretion agreement.
Learn more about this trial
Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
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