Benign Prostate Hypertrophy(BPH)
Conditions
Keywords
Prostatic Artery Embolization, PAE, SQUIDPERI, Liquid Embolic Agent
Brief summary
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.
Interventions
DEVICELiquid 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
Sponsors
Balt International
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success at 3 months | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IPSS at 12 months | Baseline and 12 months | Change in IPSS score and subscores compared to baseline. |
| IIEF-15 at 12 months | Baseline and 12 months | Change in IIEF-15 score and subscores compared to baseline. |
| QoL at 3 months | Baseline and 3 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. |
| QoL at 6 months | Baseline and 6 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. |
| QoL at 9 months | Baseline and 9 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. |
| QoL at 12 months | Baseline and 12 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. |
| IIEF-15 at 3 months | Baseline and 3 months | Change in IIEF-15 score and subscores compared to baseline. |
| IIEF-15 at 6 months | Baseline and 6 months | Change in IIEF-15 score and subscores compared to baseline. |
| IIEF-15 at 9 months | Baseline and 9 months | Change in IIEF-15 score and subscores compared to baseline. |
| IPSS at 9 months | Baseline and 9 months | Change in IPSS score and subscores compared to baseline. |
| Clinical success at 6 months | Baseline and 6 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. |
| Clinical success at 9 months | Baseline and 9 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. |
| Clinical success at 12 months | Baseline and 12 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. |
| IPSS at 3 months | Baseline and 3 months | Change in IPSS score and subscores compared to baseline. |
| IPSS at 6 months | Baseline and 6 months | Change in IPSS score and subscores compared to baseline. |
| Adverse events and serious adverse events | Up to 12 months | Number of adverse events and serious adverse events. |
| Benign prostatic hyperplasia medication at baseline | Baseline | Number of benign prostatic hyperplasia medication. |
| Benign prostatic hyperplasia medication at 3 months | 3 months | Number of benign prostatic hyperplasia medication. |
| Re-intervention for benign prostatic hyperplasia at 12 months | Up to 12 months | Rate of re-intervention for benign prostatic hyperplasia (surgery, prostatic artery embolization). |
| Immediate technical success | Embolization procedure (baseline) | Rate of immediate technical success. Immediate technical success is defined as an embolization of both lobes of the prostate using SQUID PERI. |
Countries
France
Contacts
Primary ContactTouria EL AAMRI, Project manager
Outcome results
None listed