Could blocking pelvic veins ease chronic pain in women?
NCT ID NCT06168058
First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 5 times
Summary
This study tests whether a procedure called ovarian and pelvic vein embolization can reduce chronic pelvic pain in women with pelvic varicose veins. Forty women with severe pain lasting over six months will be randomly assigned to either the embolization procedure or a diagnostic venography alone. The main goal is to see if the procedure improves pain and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ovarian vein and pelvic vein embolization (a procedure to block varicose veins in the pelvis)
- What this could lead to
- If it works, this could provide a minimally invasive treatment option for women with chronic pelvic pain caused by pelvic varicose veins.
- What could go wrong
- This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The procedure carries risks like bleeding, infection, or blood clots.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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 2. 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 3. 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 Exclusion Criteria: * 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 by study patient review committee. * 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 \<8.0 g/dL, uncorrectable INR \>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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lake Washington Vascular
WITHDRAWNBellevue, Washington, 98004, United States
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Northwell Health Physician Partners Vascular Surgery
RECRUITINGNew Hyde Park, New York, 11042, United States
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UNC School of Medicine
RECRUITINGChapel Hill, North Carolina, 27599, United States
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Weill Cornell Medicine
RECRUITINGNew York, New York, 10024, United States
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Other studies related to the condition(s) this trial covers.
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- Numbing cream may take the sting out of pelvic pain injections
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