Efficacy of Prostatic Arteries Embolization Using SQUIDPERI

N/ANot Yet RecruitingNCT07255508

Assistance Publique - Hôpitaux de Paris100 enrolled

Overview

Prostatic Artery Embolization (PAE) is a recognized mini-invasive treatment of bothersome Lower Urinary Tract Symptoms (LUTS) related to Benign Prostatic Hyperplasia (BPH). Particle embolics are used almost exclusively for embolization, with wide variation in the type and size of particles showing similar performance and safety results. Even if its durability relies on multiple risk factors, LUTS recurrence-free survival probability decreases with years. It is demonstrated that recanalization of the native prostatic artery is found in 66% of patients experiencing LUTS recurrence. Artery recanalization after several months has been reported in embolization with microparticles. The investigators addressed this issue using the liquid embolic agent SQUIDPERI in a prospective cohort of patients undergoing rePAE and showed a good clinical success rate (76.7%) at 3 months. Since then, the investigators perform initial PAE using SQUIDPERI with good results. The aim of SQUID-PAE study is to assess the efficacy of PAE using SQUIDPERI in an initial PAE setting in a multicenter prospective study.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Benign Prostate Hypertrophy(BPH)

Interventions

Liquid embolic agent

Prostatic Artery Embolization using a non-adhesive liquid embolic agent composed of an EVOH (ethylene-vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide), with micronized tantalum powder suspended within it

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years * Patient scheduled for a PAE using SquidPERI as part of routine care * Patient informed who signed the informed consent form * French social security affiliation * Good understanding of the French language Exclusion Criteria: * Patient unwilling or unlikely to comply with FU schedule * Known severe allergy to iodine * Known severe hepatic impairment * Vulnerable patient populations (such as patient under guardianship, curatorship, deprived of liberty) * Patient that already had a PAE * Patient on AME (state medical aid) * Participation in any interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable

Locations (4)

Hôpital Timone (Radiologie adultes et neuroradiologie)

Marseille, France

Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle)

Montpellier, France

Hôpital Européen Georges Pompidou - AP-HP (Radiologie Interventionnelle vasculaire et oncologique)

Paris, France

Institut Cardiovasculaire de Strasbourg (ICS) - Clinique Rhena (Radiologie interventionnelle vasculaire et oncologique)

Strasbourg, France

Outcomes

Primary Outcomes

Clinical success at 3 months

Rate of clinical success defined as an IPSS \<18 at follow-up with a decrease from baseline \> 25% AND a quality of life (QoL, last question of IPSS questionnaire) \< 4 at follow-up with a decrease from baseline ≥ 1.

Time frame: Baseline and 3 months

Secondary Outcomes

Immediate technical success

Rate of immediate technical success. Immediate technical success is defined as an embolization of both lobes of the prostate using SQUID PERI.

Time frame: Embolization procedure (baseline)

Clinical success at 6 months

Time frame: Baseline and 6 months

Clinical success at 9 months

Time frame: Baseline and 9 months

Clinical success at 12 months

Time frame: Baseline and 12 months

IPSS at 3 months

Change in IPSS score and subscores compared to baseline.

Time frame: Baseline and 3 months

IPSS at 6 months

Change in IPSS score and subscores compared to baseline.

Time frame: Baseline and 6 months

IPSS at 9 months

Change in IPSS score and subscores compared to baseline.

Time frame: Baseline and 9 months

IPSS at 12 months

Change in IPSS score and subscores compared to baseline.

Time frame: Baseline and 12 months

QoL at 3 months

Change in QoL score (last question of IPSS questionnaire) compared to baseline.

Time frame: Baseline and 3 months

QoL at 6 months

Change in QoL score (last question of IPSS questionnaire) compared to baseline.

Time frame: Baseline and 6 months

QoL at 9 months

Change in QoL score (last question of IPSS questionnaire) compared to baseline.

Time frame: Baseline and 9 months

QoL at 12 months

Change in QoL score (last question of IPSS questionnaire) compared to baseline.

Time frame: Baseline and 12 months

IIEF-15 at 3 months

Change in IIEF-15 score and subscores compared to baseline.

Time frame: Baseline and 3 months

IIEF-15 at 6 months

Change in IIEF-15 score and subscores compared to baseline.

Time frame: Baseline and 6 months

IIEF-15 at 9 months

Change in IIEF-15 score and subscores compared to baseline.

Time frame: Baseline and 9 months

IIEF-15 at 12 months

Change in IIEF-15 score and subscores compared to baseline.

Time frame: Baseline and 12 months

Adverse events and serious adverse events

Number of adverse events and serious adverse events.

Time frame: Up to 12 months

Benign prostatic hyperplasia medication at baseline

Number of benign prostatic hyperplasia medication.

Time frame: Baseline

Benign prostatic hyperplasia medication at 3 months

Number of benign prostatic hyperplasia medication.

Time frame: 3 months

Re-intervention for benign prostatic hyperplasia at 12 months

Rate of re-intervention for benign prostatic hyperplasia (surgery, prostatic artery embolization).

Time frame: Up to 12 months

Central Contacts

Touria EL AAMRI, Project manager

CONTACT

+33 (0)1 40 27 18 48 touria.el-aamri@aphp.fr

Data from ClinicalTrials.gov

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