Prostatic Artery Embolization for Benign Prostatic Obstruction

Rigshospitalet

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Hyperplasia Prostatic

Treatments: Procedure: Prostatic Artery Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT03099421

H-17000714-1

Details and patient eligibility

About

The aim of this study is to investigate the safety and efficacy of prostatic artery embolization (PAE) for patients who refuse or are not eligible for surgery with moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostate obstruction due to benign prostatic hyperplasia.

Full description

This is a prospective study investigating the safety and efficacy of PAE for patients who refuse or are not eligible for surgery and who suffers from moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostatic obstruction due to benign prostatic hyperplasia. It may form the grounding for further research in the shape of a larger randomised clinical trial.

Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS 6 months post-procedure.

1, and 6 months follow-up.

Main outcome Ability to void after removal of indwelling catheter

Secondary outcomes International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)

Enrollment: 11 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indwelling catheter secondary to benign prostatic hyperplasia (BPH) or
• Moderate-severe Obstructive LUTS secondary to BPH refractory to medical treatment
• Unsuitable for TURP or refuse surgery

Exclusion criteria

• Bladder dysfunction(and known neurological conditions affecting bladder function)
• Urethral strictures
• Bladder neck contracture
• Known sphincter anomalies
• Big bladder diverticulum or stones
• Kidney insufficiency (eGFR < 45)
• Coagulation disturbances
• Severe atheromatous or tortuosity of arteries
• Allergy to contrast medium
• Unable to undergo MR imaging
• Urological malignancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Prostatic Artery Embolization

Experimental group

Description:

Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.

Treatment:

Procedure: Prostatic Artery Embolization