Status:
COMPLETED
Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer )
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Prostatic Hyperplasia, Benign
Eligibility:
MALE
18-80 years
Phase:
NA
Brief Summary
The aim of this pilot study is to analyze the feasibility of prostatic embolization for the treatment of symptomatic benign prostatic hypertrophy with a non adhesive liquid embolic agent (Squid)
Detailed Description
Microparticle prostatic embolization is an effective technique in the short and medium term in the treatment of symptoms related to benign prostatic hyperplasia. If this technique allows an improvemen...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patient over 45 and under 80
- Benign prostatic hypertrophy with an obstructive syndrome of the lower urinary tract intolerant or refractory to medical treatment (continued for 6 months)
- Indication of prostatic embolization.
- Prostate volume of more than 40 ml
- \- Subject with an IPSS\> 18 and a Qol\> 3
- Affiliation to a social security scheme.
- Subject who has given informed consent to participate in the study.
- Exclusion criteria patient with prostate cancer or suspected of having prostate cancer
- patient with neurological bladder or AUS of extra-prostatic origin
- detrusor dysfunction
- documented allergy to iodinated contrast media
- Hepatic insufficiency
- advanced arteritis
- severe renal failure with glomerular filtration rate \<60 ml / min / 1.73 m2 body surface area
- inability to independently complete the self-questionnaires used in the study • acute or chronic prostatitis
- hydronephrosis
- diverticulum larger than 2 cm or bladder calculus
- ureteral stenosis
- active infectious syndrome
- major surgery in the four months preceding the inclusion visit
- Progressive cancer or for which the risk of progressive recovery is more than 50% in the next 5 years
- limited life expectancy
- Vulnerable persons defined in Articles L. 1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (eg: persons deprived of their liberty, minors, protected adults, etc.)
Exclusion
Key Trial Info
Start Date :
November 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05395299
Start Date
November 22 2022
End Date
October 5 2024
Last Update
February 24 2025
Active Locations (1)
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1
CHU de Nice
Nice, France, France, 06000