Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome

NCT06553014 | Completed

• 1 other identifier: ibrahim
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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 .

Conditions

Pain, Chronic

Keywords

Pelvic Congestion Syndrome, Pain,chronic pelvic pain

Outcome Measures

Primary Outcomes (1)

• onset of pain and application time for endovascular intervention

  'four months'

Study Arms (1)

Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome

Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome

Other: Endovascular Plug Embolization

Interventions

Endovascular Plug Embolization OTHER

Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome

Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halil Ibrahim Altun: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: pain specialist

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: July 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 30, 2024
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

TU (1)