title: Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial.
abstract: BACKGROUND
  Benign prostatic hyperplasia (BPH) is a prevalent entity in elderly men and transurethral resection of the prostate (TURP) still represents the gold standard of surgical treatment despite its considerable perioperative morbidity. Recently, prostatic artery embolization (PAE) was described as a novel effective and less invasive treatment alternative. Despite promising first results, PAE still has to be considered experimental due to a lack of good quality studies. Prospective randomized controlled trials comparing PAE with TUR-P are highly warranted.
  
  
  METHODS
  This is a single-centre, prospective, randomized, non-inferiority trial comparing treatment effects and adverse events of PAE and TURP in a tertiary referral centre. One hundred patients who are electable for both treatment options are randomized to either PAE or TURP. Changes of the International Prostate Symptom Score (IPSS) after 3 months are defined as primary endpoint. Changes in bladder diaries, laboratory analyses, urodynamic investigations and standardised questionnaires are assessed as secondary outcome measures. In addition contrast-enhanced magnetic resonance imaging of the pelvis before and after the interventions will provide crucial information regarding morphological changes and vascularisation of the prostate. Adverse events will be assessed on every follow-up visit in both treatment arms according to the National Cancer Institute Common Terminology Criteria for Adverse events and the Clavien classification.
  
  
  CONCLUSIONS
  The aim of this study is to assess whether PAE represents a valid treatment alternative to TURP in patients suffering from BPH in terms of efficacy and safety.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02054013.
authors.affiliation: Department of Urology, Cantonal Hospital St, Gallen, Rorschacherstrasse 95, St, Gallen 9007, Switzerland. dominik01.abt@kssg.ch.
authors.forename: Dominik
authors.initials: D
authors.lastname: Abt
authors.forename: Livio
authors.initials: L
authors.lastname: Mordasini
authors.forename: Lukas
authors.initials: L
authors.lastname: Hechelhammer
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Kessler
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Schmid
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Engeler
mesh_terms: D001158:Arteries; D004621:Embolization, Therapeutic / Q000379:methods*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011467:Prostate / Q000098:blood supply*; D011470:Prostatic Hyperplasia / Q000601:surgery / Q000628:therapy*; D020728:Transurethral Resection of Prostate