Prostatic artery embolization versus transurethral resection of the prostate in the treatment of benign prostatic hyperplasia: protocol for a non-inferiority clinical trial

Figures & data

Table 1 Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Men >60 years	Advanced atherosclerosis and tortuosity of the iliac arteries
Diagnosis of BPH with obstructive moderate-to-severe	No visualization of the prostatic artery on CT angiography
LUTS (according to the Spanish validated version of IPSS)	Urethral stenosis, detrusor failure or neurogenic bladder
Refractory to medical therapy for at least 6 months duration	Glomerular filtrate <30 mL/minute
Qmax <10 mL/second	A history of allergy to iodinated contrast
Candidate for TURP	Presence of a malignant tumor
Written informed consent obtained	Any major medical, psychological, psychiatric, geographical or uncontrolled problem that might interfere with the patient’s participation in the study or which would not allow appropriate follow-up, adherence to the protocol or evaluation of the study results Participating in another clinical trial or having done so within the 4 weeks prior to randomization

Abbreviations: BPH, benign prostatic hyperplasia; CT, computed tomography; IPSS, International Prostate Symptom Score; LUTS, lower urinary tract symptoms; Q_max, maximum urinary flow rate; TURP, transurethral resection of the prostate.

Figure 1 Timetable and assessments of the study.

Abbreviations: CT, computed tomography; IIEF, International Index of Erectile Function; IPSS, International Prostate Symptom Score; LUTS, lower urinary tract symptoms; PAE, prostatic artery embolization; PSA, prostate-specific antigen; PVR, postvoid residual volume; Q_max, peak urinary flow maximum; QoL, quality of life; TURP, transurethral resection of the prostate.