Pain, ChronicNCT06553014
Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome
An observational study of Pain, Chronic, run by Halil Ibrahim Altun at 1 site in Turkey (Türkiye).
Trial summary
Pelvic Congestion Syndrome (PKS) is generally seen in female patients of reproductive age and is characterized by abdominopelvic pain and a feeling of fullness in the perineum and vulva. Patients may also be accompanied by dysmenorrhea , dyspareunia, postcoital pain, dysuria , hematuria, waist and hip pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Endovascular Plug Embolization
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Sep 2024
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria: * 18 years of age * with abdominopelvic pain for more than 6 months , * with clinical, physical examination and symptoms , and with >6 mm dilatation in the pelvic veins on transvaginal or transabdominal ultrasound (USG) were included in the study. * It was performed by a radiologist with at least 10 years of experience in the field of USG
exclusion criteria: -Gynecologically, patients with leiomyoma, pelvic inflammatory disease, endometriosis , postoperative adhesion,
- Patients who have undergone urological and gynecological surgery,
- Patients with chronic renal failure,
- Patients with known allergies to the drugs used during the procedure ,
- Patients with abdominopelvic trauma, malignancy or its history,
- Patients with a history of radiotherapy chemotherapy,
- Patients with known psychiatric disease,
- Pregnant women,
- Breastfeeding women,
- Patients with fibromyalgia ,
- Known lumbar disc herniation, scoliosis, facet syndrome, sacroiliac dysfunction, and patients with genitourinary and gastrointestinal diseases were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 34000
About this study
Pelvic Congestion Syndrome (PKS) is generally seen in female patients of reproductive age and is characterized by abdominopelvic pain and a feeling of fullness in the perineum and vulva. Patients may also be accompanied by dysmenorrhea , dyspareunia, postcoital pain, dysuria , hematuria, waist and hip pain. The pain usually increases with standing and decreases with lying down. PCS is one of the causes of chronic pelvic pain (CPA). As in CPA , it lasts longer than 6 months and is independent of the menstrual cycle. Its etiopathogenesis has not been fully elucidated. at PKS There is dilatation in the ovarian veins. In the current definition, diseases that involve dilatation of the veins in the pelvic region and were referred to by different names in the past are called Pelvic Venous Disease .
There is no consensus on the diagnostic criteria for PCS . Catheter venography along with the patient's clinical findings is still the gold standard in diagnosis. Among non- invasive methods , >0.6 mm dilatation in the ovarian veins on transvaginal or transabdominal ultrasound (USG) is one of the most important findings of PCS .
Read more
There have been significant changes in its treatment in recent years. Some of the hormone treatments used in the 1980s were abandoned due to their side effects. Some flavonoid fraction drugs are used in PCS due to their vasoactive effects . Anti-inflammatory drugs, paracetamol, are preferred for analgesic purposes , and gabapentinoids and antidepressants are preferred for central sensitization . In the same years, hysterectomy and single or bilateral oophorectomy were performed by gynecologists. Laparoscopic ovarian vein ligation began to be performed in the 2000s , but it lost its popularity due to serious complications such as hematoma in the retroperitoneum and ureteral injury . Today, some endovascular sclerosing drugs, foam, plug and coil embolization techniques are frequently used alone or in combination in the treatment of PCS . There are studies on the low complications and high effectiveness of these treatments .
Diagnosis and treatment of PCS patients, who frequently apply to urology and gynecology, are often delayed, patients are followed up with different diagnoses, and the cost increases. Endovascular intervention is a minimally invasive technique and patients are discharged on the same day. There are approximately 3 times more studies in the literature ( PUBMED, EMBASE, MEDLINE (OVID), Web of Science ) on coil embolization , one of the endovascular methods used , than on plug treatment (9). We aimed to contribute to the limited literature on the effectiveness of plug therapy in PCS patients with limited access to diagnosis and treatment .
Read the detailed description
Patients diagnosed with pelvic congestion syndrome who underwent endovascular procedures using the plug method in the cardiovascular surgery clinic of our hospital between January 2023 and March 2024 were examined. The study was conducted in accordance with the Declaration of Helsinki. The study was conducted retrospectively with 32 patients who met the criteria.
18 years of age , with abdominopelvic pain for more than 6 months , with clinical, physical examination and symptoms , and with >6 mm dilatation in the pelvic veins on transvaginal or transabdominal ultrasound (USG) were included in the study. It was performed by a radiologist with at least 10 years of experience in the field of USG.
Gynecologically, patients with leiomyoma, pelvic inflammatory disease, endometriosis , postoperative adhesion, patients who have undergone urological and gynecological surgery, patients with chronic renal failure, patients with known allergies to the drugs used during the procedure , patients with abdominopelvic trauma, malignancy or its history, patients with a history of radiotherapy chemotherapy, patients with known psychiatric disease, Pregnant women, breastfeeding women, patients with fibromyalgia , known lumbar disc herniation, scoliosis, facet syndrome, sacroiliac dysfunction, and patients with genitourinary and gastrointestinal diseases were excluded from the study.
Patients' age, body mass index (BMI), painful areas (perineum, vulva, labia major/minor, hypogastrium , inguinal region, hip, waist, leg) and painful side, medical treatments, additional diseases, onset of pain and application for endovascular intervention. duration, symptoms accompanying pain ( feeling of heaviness in the perineum , labia swelling in the majora , Dysuria , Hematuria, Dyspareunia , Postcoital pain, Dysmenorrhea , frequent urination) In which position does the pain increase: lying down: (supine / prone / lateral) standing / sitting, presence of varicose veins in the lower extremity , vein entered during endovascular intervention, embolized vein, embolotherapy type, procedure time (min), cumulative radiation exposure during the procedure (mGy- m2 ) Complications observed during the procedure (Vessel perforation / Hematoma / Phlebitis / Embolism / Migration / Vasovagal / Dyspnea / Panic attack / Allergy / Infection) and the need for repeated procedures were recorded in the patient follow-up form.
For pain and functionality evaluation, NRS-11 scores and SF-12 scores were recorded before and at the first and third months after the endovascular procedure.
- Numeric Rating Scale-11 ( NRS - 11 ) is an 11-point numerical scale where patients can evaluate their pain between 0 (no pain) and 10 (the most severe pain they have ever felt in their life) .
- Short form-12 (SF-12): It is a scale that evaluates patients' quality of life levels. Short Form-12 is the abbreviation of Short Form-36. In SF-12, the patient's general health status, physical and mental functions, quality of life and social activities are questioned. It is scored between 0-100. A high score is associated with good general health status. It is a validated scale. This test was applied 3 times: before treatment, 1 month and 3 months after treatment.
- Conditions
- Pain, Chronic
- Being tested
- Endovascular Plug Embolization
- Keywords
- Pelvic Congestion Syndrome, Pain,chronic pelvic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Plug EmbolizationOther
Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome
| Study group | Role | What they receive |
|---|---|---|
| Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome | Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome Receives: Other: Endovascular Plug Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset of pain and application time for endovascular intervention
Measured: 'four months'
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Jul 2024
- Primary completion1 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halil Ibrahim Altun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553014
- Sponsor's protocol ID
- ibrahim
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome
- ClinicalTrials.gov ID
- NCT06553014
- Acronym / sponsor ID
- ibrahim
- Conditions
- Pain, Chronic
- Keywords
- Pelvic Congestion Syndrome, Pain,chronic pelvic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Halil Ibrahim AltunUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 14 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.
Pelvic Congestion Syndrome (PKS) is generally seen in female patients of reproductive age and is characterized by abdominopelvic pain and a feeling of fullness in the perineum and vulva. Patients may also be accompanied by dysmenorrhea , dyspareunia, postcoital pain, dysuria , hematuria, waist and hip pain. The pain usually increases with standing and decreases with lying down. PCS is one of the causes of chronic pelvic pain (CPA). As in CPA , it lasts longer than 6 months and is independent of the menstrual cycle. Its etiopathogenesis has not been fully elucidated. at PKS There is dilatation in the ovarian veins. In the current definition, diseases that involve dilatation of the veins in the pelvic region and were referred to by different names in the past are called Pelvic Venous Disease .
There is no consensus on the diagnostic criteria for PCS . Catheter venography along with the patient's clinical findings is still the gold standard in diagnosis. Among non- invasive methods , >0.6 mm dilatation in the ovarian veins on transvaginal or transabdominal ultrasound (USG) is one of the most important findings of PCS .
There have been significant changes in its treatment in recent years. Some of the hormone treatments used in the 1980s were abandoned due to their side effects. Some flavonoid fraction drugs are used in PCS due to their vasoactive effects . Anti-inflammatory drugs, paracetamol, are preferred for analgesic purposes , and gabapentinoids and antidepressants are preferred for central sensitization . In the same years, hysterectomy and single or bilateral oophorectomy were performed by gynecologists. Laparoscopic ovarian vein ligation began to be performed in the 2000s , but it lost its popularity due to serious complications such as hematoma in the retroperitoneum and ureteral injury . Today, some endovascular sclerosing drugs, foam, plug and coil embolization techniques are frequently used alone or in combination in the treatment of PCS . There are studies on the low complications and high effectiveness of these treatments .
Diagnosis and treatment of PCS patients, who frequently apply to urology and gynecology, are often delayed, patients are followed up with different diagnoses, and the cost increases. Endovascular intervention is a minimally invasive technique and patients are discharged on the same day. There are approximately 3 times more studies in the literature ( PUBMED, EMBASE, MEDLINE (OVID), Web of Science ) on coil embolization , one of the endovascular methods used , than on plug treatment (9). We aimed to contribute to the limited literature on the effectiveness of plug therapy in PCS patients with limited access to diagnosis and treatment .
Detailed description
Patients diagnosed with pelvic congestion syndrome who underwent endovascular procedures using the plug method in the cardiovascular surgery clinic of our hospital between January 2023 and March 2024 were examined. The study was conducted in accordance with the Declaration of Helsinki. The study was conducted retrospectively with 32 patients who met the criteria.
18 years of age , with abdominopelvic pain for more than 6 months , with clinical, physical examination and symptoms , and with >6 mm dilatation in the pelvic veins on transvaginal or transabdominal ultrasound (USG) were included in the study. It was performed by a radiologist with at least 10 years of experience in the field of USG.
Gynecologically, patients with leiomyoma, pelvic inflammatory disease, endometriosis , postoperative adhesion, patients who have undergone urological and gynecological surgery, patients with chronic renal failure, patients with known allergies to the drugs used during the procedure , patients with abdominopelvic trauma, malignancy or its history, patients with a history of radiotherapy chemotherapy, patients with known psychiatric disease, Pregnant women, breastfeeding women, patients with fibromyalgia , known lumbar disc herniation, scoliosis, facet syndrome, sacroiliac dysfunction, and patients with genitourinary and gastrointestinal diseases were excluded from the study.
Patients' age, body mass index (BMI), painful areas (perineum, vulva, labia major/minor, hypogastrium , inguinal region, hip, waist, leg) and painful side, medical treatments, additional diseases, onset of pain and application for endovascular intervention. duration, symptoms accompanying pain ( feeling of heaviness in the perineum , labia swelling in the majora , Dysuria , Hematuria, Dyspareunia , Postcoital pain, Dysmenorrhea , frequent urination) In which position does the pain increase: lying down: (supine / prone / lateral) standing / sitting, presence of varicose veins in the lower extremity , vein entered during endovascular intervention, embolized vein, embolotherapy type, procedure time (min), cumulative radiation exposure during the procedure (mGy- m2 ) Complications observed during the procedure (Vessel perforation / Hematoma / Phlebitis / Embolism / Migration / Vasovagal / Dyspnea / Panic attack / Allergy / Infection) and the need for repeated procedures were recorded in the patient follow-up form.
For pain and functionality evaluation, NRS-11 scores and SF-12 scores were recorded before and at the first and third months after the endovascular procedure.
- Numeric Rating Scale-11 ( NRS - 11 ) is an 11-point numerical scale where patients can evaluate their pain between 0 (no pain) and 10 (the most severe pain they have ever felt in their life) .
- Short form-12 (SF-12): It is a scale that evaluates patients' quality of life levels. Short Form-12 is the abbreviation of Short Form-36. In SF-12, the patient's general health status, physical and mental functions, quality of life and social activities are questioned. It is scored between 0-100. A high score is associated with good general health status. It is a validated scale. This test was applied 3 times: before treatment, 1 month and 3 months after treatment.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome | – | Other: Endovascular Plug EmbolizationEffectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * 18 years of age * with abdominopelvic pain for more than 6 months , * with clinical, physical examination and symptoms , and with >6 mm dilatation in the pelvic veins on transvaginal or transabdominal ultrasound (USG) were included in the study. * It was performed by a radiologist with at least 10 years of experience in the field of USG
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 |
|---|---|---|
| Endovascular Plug EmbolizationEffectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome | Other | Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome |
Primary outcome
onset of pain and application time for endovascular intervention
Time frame: 'four months'
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain, Chronic, run by Halil Ibrahim Altun at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 8 Jan 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset of pain and application time for endovascular intervention (time frame: 'four 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 8 Jan 2026.