Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer ) (SQUID)

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

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)

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia, Benign
• Intervention / Treatment: Procedure: SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization

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 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer ); Injection at the level of the right and left prostate arteries of Squid until a complete occlusion of these arteries, and a filling of their intraprostatic branches	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 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the causes of technical embolization failures	Injection into the 2 prostate lobes	day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): October 5, 2024

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Growth Substances; Plant Growth Regulators; Ethylene
• Other Study ID Numbers: 21-PP-21; 2021-A02956-35 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No