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New treatment option for Chronic Pelvic Pain Syndrome
Official title Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
ClinicalTrials.gov ID: NCT06168058
What this study is testing
- What it's testing
- The purpose of this study is to see if a randomized controlled trial of ovarian vein and pelvic vein embolization versus venography alone could determine outcomes for women with chronic pelvic pain and pelvic varicose veins. The data gathered will assist in addressing changes in quality of life in patients who have ovarian/pelvic vein embolization versus no embolization.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only. Healthy volunteers may be eligible.
You may be able to join if
- Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7 as determined by 4 consecutive weeks of baseline self-assessments)...
- Pain exacerbated by walking, standing or lifting
- Symptoms are at least partially alleviated by lying down
- Prolonged post-coital ache
- Absence of non-venous origin CPP as determined by Gynecology examination
You likely can't join if
- Female \<18 years of age
- Pregnancy (positive pregnancy test)
- Female subject who plans to become pregnant during study period
- Female subject who is actively breastfeeding
- Patient who is post-menopausal or anovulatory with hormone suppression
- History of prior hysterectomy
See the full eligibility criteria
- Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7 as determined by 4 consecutive weeks of baseline self-assessments) despite non-vascular therapy as delineated by the following criteria:
- Pain exacerbated by walking, standing or lifting
- Symptoms are at least partially alleviated by lying down
- Prolonged post-coital ache
- Absence of non-venous origin CPP as determined by Gynecology examination
- Symptoms-Varices-Pathophysiology Classification18 including of one of the following: S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT
- CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors
- Left or right ovarian vein diameter greater than or equal to 6 mm as documented by TAUS or CT
- Presence of intrabdominal/pelvic varices as documented by TAUS or CT (≥1 veins, \>5 mm diameter)
- Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis
- Female \<18 years of age
- Pregnancy (positive pregnancy test)
- Female subject who plans to become pregnant during study period
- Female subject who is actively breastfeeding
- Patient who is post-menopausal or anovulatory with hormone suppression
- History of prior hysterectomy
- Prior ovarian vein embolization or ovarian vein ligation
- Inability to tolerate endovascular procedure due to acute illness or general health
- Planned simultaneous treatment with nerve blocks during the duration of the study
- Laparoscopy or planned surgical intervention during the duration of the study
- Known allergy to sclerosant, coil, stent or catheter components including nickel allergy
- Any iliac vein stenosis determined identified by the investigator on pelvic DUS, CT venogram, and/or Catheter Venography and deemed significant for exclusion by study patient review committee.
- Any renal vein stenosis with resultant renal hilar varices/collaterals and lumbar collaterals identified by the investigator on pelvic DUS, CT venogram, and/or Diagnostic Venography and deemed significant for exclusion...
- Presence of isolated extra-pelvic vulvar and/or lower extremity varices without intrabdominal pelvic varices. Primary S3 categorization study exclusion.
- Serious medical conditions that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF, etc.)
- Severe allergy to iodinated or gadolinium-based contrast refractory to steroid premedication
- Severe renal impairment (on chronic dialysis or estimated GFR \<30 mL/min)
- Hemoglobin \ 3.0 or platelet count \<75,000/microliter
- Inability to provide informed consent or to comply with study assessments
- Post thrombotic IVC, iliac or ovarian vein changes
The study team makes the final eligibility decision.
Where it's taking place
- New Hyde Park, New York, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Bellevue, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Hyde Park, New York, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Bellevue, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.