Status:
COMPLETED
Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Over the last 5 years, prostate embolization has developed as a treatment for symptomatic prostate adenoma. This long, complex procedure is effective in 80% of cases. Currently there are no means of b...
Detailed Description
The hypothesis is that there are two types of prostate vascularization in patients with symptomatic prostate adenoma: * prostates mainly vascularized by large caliber prostate arteries with high flow...
Eligibility Criteria
Inclusion
- Patients with symptomatic benign prostatic hypertrophy (prostate volume \> 50, IPSS \>7, QoL\>2) or patients catheterized after acute retention of urine with failed catheterization.
- Creatinine clearance \> 30 mL/min for one of the two Cockcroft-Gault/MDRD equations)
- Adult patients (≥18 years).
- Patients with an indication for prostate embolization.
- Patient with free and informed consent.
- Patient who have signed the consent form.
- Patient affiliated or beneficiary of a health insurance plan.
Exclusion
- Hypersensitivity to the active substance or to one of the excipients of the iodized contrast medium.
- Severe renal impairment with renal function \<30mL/min.
- Contraindication to prostate embolization (aorto-iliac bypass)
- Patient participating in research defined as Category 1 Research Involving Human Subjects.
- Patient in an exclusion period as determined by another study.
- Patient under court protection, guardianship or curatorship.
- Patient unable to give consent.
- Patient for whom it is impossible to give informed information.
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05389202
Start Date
May 12 2022
End Date
January 19 2024
Last Update
March 10 2025
Active Locations (1)
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1
Nîmes University Hospital
Nîmes, Gard, France, 30029