Glue EmbolizationNCT06560294
Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome
A study testing Micronized purified flavonoid fraction (Daflon ®) and Glue embolization in people with Glue Embolization and Pelvic Congestion Syndrome, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Glue Embolization, Pelvic Congestion Syndrome
- What is being tested?
- Micronized purified flavonoid fraction (Daflon ®) and Glue embolization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Aug 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged from 30 to 50 years.
- Complaining from pelvic congestion syndrome.
Who cannot join
- Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.
- Patients who are treated with opiates to reduce pelvic pain in the period before the study.
- Patient with history of contrast allergy
- Patient with renal impairment
- Patient has alternative gynecological cause of chronic pelvic pain as pelvic inflammatory disease (PID), endometriosis, fibroid, adenomyosis, ovarian cyst
- Patient underwent any previous intervention for pelvic congestion syndrome as laparoscopy or surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, ElGharbia, 31527
Mohamed I Eleissawy, MD, 00201110036328, mohamed.elesawy@med.tanta.edu.eg
Hossam M Khalil, MD
About this study
Official title: Glue Embolization Versus Conservative Treatment for Pelvic Congestion Syndrome: A Randomized Trial
The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.
Read the detailed description
Pelvic congestion syndrome (PCS) is a common cause of chronic lower abdominal/pelvic pain, estimated to affect about 40 % of women, predominantly between the ages of 30 and 45.The treatment of PCS depends mainly on the severity of the pain. Non-steroid anti-inflammatory drugs are often used, and contraceptives have a role in cases of pain associated predominantly with menstruation.
Traditionally, conservative approaches, such as pharmacotherapy with venoactive drugs like micronized purified flavonoid fraction (Daflon), have been utilized to address the symptoms of PCS. Daflon has been used to treat venous insufficiency and has demonstrated efficacy in reducing symptoms and improving the quality of life in patients with PCS. Its mechanism of action includes improving venous tone, reducing venous stasis, and exerting anti-inflammatory effects. Endovascular treatment of PCS is challenging and requires occlusion of incompetent pelvic veins.
- Conditions
- Glue Embolization, Pelvic Congestion Syndrome
- Being tested
- Micronized purified flavonoid fraction (Daflon ®), Glue embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized purified flavonoid fraction (Daflon ®)Drug
Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months.
Glue embolizationOther
Patients will receive transcatheter glue embolization.
| Study group | Role | What they receive |
|---|---|---|
| Micronized purified flavonoid fraction (Daflon ®) | Active comparator | Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months. Receives: Drug: Micronized purified flavonoid fraction (Daflon ®) |
| Glue embolization | Experimental | Patients will receive transcatheter glue embolization. Receives: Other: Glue embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Degree of pain will be assessed using a Visual Analog Scale (VAS). The VAS is a self-reported scale consisting of a horizontal or vertical line, usually 10 cm long. An introductory question asks the patient to mark a point on the line that best refers to his or her pain. Patients will be encouraged to assess the intensity of subjective manifestation of each symptom by scoring from 0 (no symptom) to 10 (the most extreme manifestation possible).
Measured: Post intervention for 3 months
Secondary outcomes (2)
Incidence of recurrence of pain
Incidence of recurrence of pain will be recorded.
Measured: Post intervention for 3 months
Pelvic Venous Clinical Severity Score (PVCSS)
Assessment of treatment outcomes will be standardized using the disease-specific Pelvic Venous Clinical Severity Score (PVCSS) for female patients with pelvic congestion syndrome. The PVCSS takes into account 10 major symptoms and signs of the disease, each of which is scored from 0 (no symptom) to 3 (maximum severity) for a maximum score of 30, which indicates an extremely severe degree of disease.
Measured: Post intervention for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start17 Aug 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glue EmbolizationStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Adel Eleissawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560294
- Sponsor's protocol ID
- 36264PR752/7/24
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glue Embolization Versus Conservative Treatment for Pelvic Congestion Syndrome: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06560294
- Acronym / sponsor ID
- 36264PR752/7/24
- Conditions
- Glue Embolization, Pelvic Congestion Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 17 Aug 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Aug 2024 (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.
The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.
Detailed description
Pelvic congestion syndrome (PCS) is a common cause of chronic lower abdominal/pelvic pain, estimated to affect about 40 % of women, predominantly between the ages of 30 and 45.The treatment of PCS depends mainly on the severity of the pain. Non-steroid anti-inflammatory drugs are often used, and contraceptives have a role in cases of pain associated predominantly with menstruation.
Traditionally, conservative approaches, such as pharmacotherapy with venoactive drugs like micronized purified flavonoid fraction (Daflon), have been utilized to address the symptoms of PCS. Daflon has been used to treat venous insufficiency and has demonstrated efficacy in reducing symptoms and improving the quality of life in patients with PCS. Its mechanism of action includes improving venous tone, reducing venous stasis, and exerting anti-inflammatory effects. Endovascular treatment of PCS is challenging and requires occlusion of incompetent pelvic veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micronized purified flavonoid fraction (Daflon ®) | Active comparator | Drug: Micronized purified flavonoid fraction (Daflon ®)Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months. |
| Glue embolization | Experimental | Other: Glue embolizationPatients will receive transcatheter glue embolization. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged from 30 to 50 years.
- Complaining from pelvic congestion syndrome.
Key exclusion criteria (6 listed)
- Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.
- Patients who are treated with opiates to reduce pelvic pain in the period before the study.
- Patient with history of contrast allergy
- Patient with renal impairment
- Patient has alternative gynecological cause of chronic pelvic pain as pelvic inflammatory disease (PID), endometriosis, fibroid, adenomyosis, ovarian cyst
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 |
|---|---|---|
| Micronized purified flavonoid fraction (Daflon ®)Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months. | Drug | Micronized purified flavonoid fraction (Daflon ®) |
| Glue embolizationPatients will receive transcatheter glue embolization. | Other | Glue embolization |
Primary outcome
Degree of pain
Time frame: Post intervention for 3 months
Degree of pain will be assessed using a Visual Analog Scale (VAS). The VAS is a self-reported scale consisting of a horizontal or vertical line, usually 10 cm long. An introductory question asks the patient to mark a point on the line that best refers to his or her pain. Patients will be encouraged to assess the intensity of subjective manifestation of each symptom by scoring from 0 (no symptom) to 10 (the most extreme manifestation possible).
2 secondary outcomes
Incidence of recurrence of pain
Time frame: Post intervention for 3 months
Pelvic Venous Clinical Severity Score (PVCSS)
Time frame: Post intervention for 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronized purified flavonoid fraction (Daflon ®) and Glue embolization in people with Glue Embolization and Pelvic Congestion Syndrome, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Aug 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed I Eleissawy, MD (00201110036328, mohamed.elesawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: Post intervention for 3 months). 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 19 Aug 2025.