Glue or coils? new study aims to settle best fix for pelvic pain
NCT ID NCT07221695
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways to treat pelvic congestion syndrome, a condition that causes long-term pelvic pain. About 60 women aged 18–50 with moderate to severe pain will receive either foam plus medical glue or foam plus tiny coils to block the faulty vein. Researchers will track pain relief and symptom improvement over 18 months to see which method works better.
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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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2025
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.
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 * Female patients aged 18 to 50 years * Clinically suspected pelvic venous disorder (PVD), presenting with chronic pelvic pain ≥ 6 months * Pelvic pain intensity ≥ 4 on a 10-point Visual Analogue Scale (VAS) at baseline * No evidence of significant venous obstruction or internal iliac insufficiency * Willingness to participate, provide written informed consent, and comply with study visits and procedures exclusion criteria * Pregnancy or planning to conceive within the next 12 months * Significant Nutcracker syndrome diagnosed by duplex / CTV / MRV * Significant May-Thurner syndrome diagnosed by duplex / CTV / MRV * Non-ovarian sources of reflux requiring intervention, including internal iliac vein insufficiency; During venography all patients will undergo selective pelvic venography prior embolization to exclude patients who have combined gonadal and internal iliac vein reflux) * History of previous pelvic vein embolization or surgical ligation * Coagulopathy, defined as: * INR \> 1.5 * Platelet count \< 50 × 10⁹/L * Severe comorbidities, including: * Active pelvic infection (e.g., pelvic inflammatory disease) * End-stage renal disease (eGFR \< 30 mL/min/1.73 m²) * Decompensated heart failure (NYHA class III-IV) * Active malignancy requiring treatment Known allergy or hypersensitivity to: * Iodinated contrast media * Polidocanol (Aethoxysklerol®) * N-butyl cyanoacrylate (e.g., Gluebran® 2) * Nickel, platinum, or stainless steel (components of embolization coils) . Presence of non-venous pelvic pathology requiring immediate management
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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
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
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Contacts and locations
Locations
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Kafr El Shaykh University
Kafr ash Shaykh, Kafrelshaykh Governorate, 33511, Egypt
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