NCT05395299

Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer )

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Prostatic Hyperplasia, Benign

Interventions

Type	Name	Description
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 )

Timeline

• Start date: 2022-11-22
• Primary completion: 2023-11-22
• Completion: 2024-10-05
• First posted: 2022-05-27
• Last updated: 2025-02-24

Locations

1 site across 1 country: France