Clinical trial NCT02054013: Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia
Official title: Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 101
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes in the International Prostate Symptom Score
timeFrame: Baseline and 12 weeks after intervention
Secondary outcomes:
measure: Changes of prostate volume using Magnetic Resonance Imaging
timeFrame: Baseline, 12 weeks and 24 months after intervention
measure: Changes in bladder diary
timeFrame: Baseline and at all follow up controls
measure: Pre- and postoperative changes in C-reactive Protein, Prostate-specific antigen (PSA), serum amyloid A, Interleukin-6 and Interleukin-10
timeFrame: Baseline and 1 day, 2 days, 1 and 6 weeks post intervention
measure: Changes in urodynamic parameters
timeFrame: Baseline and 12 and 24 months after intervention
measure: Duration of hospitalization post procedure
timeFrame: hospital discharge
measure: Duration of post procedure catheterization
timeFrame: baseline and post intervention
measure: Changes in the CPSI and IIEF
timeFrame: baseline and at all follow-up controls after the intervention
measure: Procedure time and radiation parameters
timeFrame: after intervention
measure: 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
timeFrame: baseline
measure: Percentage of prostate tissue devascularized, based on contrast-enhanced MRI
timeFrame: 12 weeks and 24 months after intervention
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Daniel Engeler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.