Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia

Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia

Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Trial

Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Medical therapy is usually the first-line treatment. However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration. In cases with moderate to severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the procedure is associated with a complication rate. The cumulative short-term morbidity rate is around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring transfusions and transurethral resection syndrome represent potentially serious threats to elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure, which can be performed in an outpatient setting with rapid recovery and low morbidity. The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH compared to conventional and established TUR-P.

Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure with rapid recovery and low morbidity

Changes in bladder diary (difference of voids during daytime and night-time, difference voided volume, difference liquid intake, difference incontinence episodes)

Pre- and postoperative changes in C-reactive Protein, Prostate-specific antigen (PSA), serum amyloid A, Interleukin-6 and Interleukin-10

Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size measured by TRUS and MRI

Inclusion Criteria: Men older than 40 Patient must be a candidate for TURP Refractory to medical therapy or patient is not willing to consider (further) medical treatment Patient has a prostate size of at least 25 ml and not more than 80 ml, measured by ultrasound IPSS ≥8 QoL ≥3 Qmax<12 and/or urinary retention Written informed consent Exclusion Criteria: Mild symptoms (IPSS <8) Severe atherosclerosis Severe tortuosity in the aortic bifurcation or internal iliac arteries Acontractile detrusor Neurogenic lower urinary tract dysfunction Urethral stenosis Bladder diverticulum Bladder stone with surgical indication Allergy to intravenous contrast media Contraindication for MRI imaging Preinterventionally proven adenocarcinoma of the prostate Renal failure (GFR<60ml/min)

Abt D, Mordasini L, Hechelhammer L, Kessler TM, Schmid HP, Engeler DS. Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial. BMC Urol. 2014 Nov 25;14:94. doi: 10.1186/1471-2490-14-94.

Abt D, Hechelhammer L, Mullhaupt G, Markart S, Gusewell S, Kessler TM, Schmid HP, Engeler DS, Mordasini L. Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial. BMJ. 2018 Jun 19;361:k2338. doi: 10.1136/bmj.k2338.

Mullhaupt G, Hechelhammer L, Diener PA, Engeler DS, Gusewell S, Schmid HP, Mordasini L, Abt D. Ejaculatory disorders after prostatic artery embolization: a reassessment of two prospective clinical trials. World J Urol. 2020 Oct;38(10):2595-2599. doi: 10.1007/s00345-019-03036-7. Epub 2019 Dec 7.

Mullhaupt G, Hechelhammer L, Engeler DS, Gusewell S, Betschart P, Zumstein V, Kessler TM, Schmid HP, Mordasini L, Abt D. In-hospital cost analysis of prostatic artery embolization compared with transurethral resection of the prostate: post hoc analysis of a randomized controlled trial. BJU Int. 2019 Jun;123(6):1055-1060. doi: 10.1111/bju.14660. Epub 2019 Jan 28.

Abt D, Mullhaupt G, Hechelhammer L, Markart S, Gusewell S, Schmid HP, Mordasini L, Engeler DS. Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: 2-yr Outcomes of a Randomised, Open-label, Single-centre Trial. Eur Urol. 2021 Jul;80(1):34-42. doi: 10.1016/j.eururo.2021.02.008. Epub 2021 Feb 19.