Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553014
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Endovascular Plug Embolization in Pelvic Congestion Syndrome
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients clinical findings is still the gold standard in diagnosis Among non- invasive methods 06 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
There is no consensus on the diagnostic criteria for PCS Catheter venography along with the patients clinical findings is still the gold standard in diagnosis Among non- invasive methods 06 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 majorminor 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
1 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
2 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 patients 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
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 majorminor 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
1 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
2 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None