Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer )

Prostatic Hyperplasia, Benign Clinical Trial

— SQUID  

Official title:

Feasibility of Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer ) in Symptomatic Patients With Benign Prostatic Hyperplasia: Monocentric Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05395299
• Other study ID #: 21-PP-21
• Secondary ID: 2021-A02956-35
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: October 3, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 improvement of the patients' symptoms, and fewer operative complications than urological interventions, on the other hand, the injection of arterial particles has several disadvantages: a random long-term durability mainly due to a revascularization of the embolized territories ; inferiority compared to urological treatments in terms of reduction of prostate volume and improvement of postoperative urodynamic tests; poor visualization of the embolization material, and a risk of injection of the particles into an artery supplying a non-target organ. Ethylene vinyl alcohol copolymer is a liquid embolism used for the endovascular treatment of cerebral arteriovenous malformations since 2005 and in specific extracerebral applications due to its advantageous physical properties (its viscous nature, its slow polymerization, its definitive and very distal occlusion, and its high fluoroscopic visibility). These properties would allow in prostatic embolization: to obtain better control during the injection and therefore to improve the safety of the embolization; to reduce the risk of recurrence; and to achieve a more intense prostatic ischemia and therefore to obtain a greater reduction in prostatic volume, and a better improvement in urodynamic tests. The aim of this pilot study is to analyze the feasibility of injecting this liquid embolic agent during the endovascular treatment of symptomatic benign prostatic hypertrophy. If this preliminary study is positive, a randomized phase III study could be undertaken to judge the results and the place of this technique in the treatment of symptoms related to benign prostatic hyperplasia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: October 3, 2024
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia
• Prostatic Hyperplasia, Benign

Intervention

Procedure:
• SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization
Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main objective is to study the feasibility of prostate embolization with SQUID	squid injection success in the prostate assessed by a scanner	day 0
Secondary	Description of the causes of technical embolization failures	Injection into the 2 prostate lobes	day 0