New procedure aims to silence pelvic pain for good
NCT ID NCT07472504
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a procedure that blocks abnormal veins in the pelvis to relieve chronic pelvic pain caused by Pelvic Congestion Syndrome. It involves 100 women aged 18-60 who have had pain for over 6 months. The goal is to see if the procedure significantly reduces pain and other symptoms like pain during sex or heavy feelings in the pelvis.
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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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * • Adult females aged 18 -60 years. * Clinical symptoms consistent with PCS \>6 months refractory to conservative treatment(e.g., chronic pelvic pain (CPP) of at least 6 months duration, unresponsive to conventional pain management strategies and worsening with standing, dyspareunia, pelvic heaviness, presence of vulvar/perineal/thigh varices and ovarian point tenderness during examination in patients with history of post-coital pain). * Symptom Correlation: Pelvic pain is deemed to be significantly attributable to the identified iliac venous compression after multidisciplinary assessment for exclusion of the other causes of chronic pelvic pain (e.g., gynaecologist, urologist, pain specialist). * Imaging-confirmed non-thrombotic iliac venous outflow stenosis or occlusion with ovarian and/or pelvic venous reservoir reflux (e.g., cross-sectional area reduction on direct CT venography, MR venography or digital subtraction angiography) * Informed Consent: Willingness and ability to provide written informed consent prior to study-specific procedures. * Adherence to Follow-up: Willingness and ability to comply with scheduled follow-up visits and study procedures. Exclusion Criteria: * Primary Pelvic Congestion Syndrome (PCS) only: Patients with significant pelvic venous reflux (e.g., ovarian or internal iliac vein reflux) without demonstrable and significant iliac venous outflow obstruction (i.e., primary PCS without secondary component). * Pelvic Congestion Syndrome secondary to Nutcracker syndrome. * Acute Deep Vein Thrombosis (DVT) on the affected side or known uncontrolled hypercoagulable states. * Contraindications to Anticoagulation: Known severe coagulopathy or absolute contraindications to the required antiplatelet and/or anticoagulant therapy post-stenting. * Pregnancy. * Severe Systemic Illness: Patients with severe, uncontrolled systemic diseases (e.g., severe renal failure, uncontrolled heart failure, uncontrolled hypertension, severe liver dysfunction) that would preclude safe participation in an invasive procedure or confound symptom assessment. * Active Infection: Any active systemic or localized infection, particularly at the access site. * Malignancy: Known active malignancy, especially pelvic malignancy, which could be the primary cause of pelvic pain or venous compression. * Other Dominant Causes of Pelvic Pain: Clear evidence of other treatable and dominant causes of chronic pelvic pain (e.g., severe endometriosis, adenomyosis, large uterine fibroids, severe interstitial cystitis, inflammatory bowel disease) that have not been adequately addressed or where these conditions are considered the primary source of pain. * Known Allergy: Documented severe allergy to contrast media or any components of the embolizing materials that cannot be managed. * Inability to Consent or Cooperate: Patients with cognitive impairment, psychological instability, or uncooperative behavior that would prevent informed consent or adherence to study procedures and follow-up.
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Conditions
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The official record
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