Aquablation versus holmium laser enucleation of the prostate in the treatment of benign prostatic hyperplasia in medium-to-large-sized prostates (ATHLETE): protocol of a prospective randomised trial

INTRODUCTION: A novel method for the surgical treatment of benign prostatic hyperplasia (BPH) called Aquablation has become commercially available. Previous studies have been able to show similar functional results when compared with transurethral resection of the prostate and a high efficacy has been demonstrated when this approach is applied to patients with a prostate size of 80–150 cm(3). Holmium laser enucleation of the prostate (HoLEP) is a well-established procedure in the surgical treatment of BPH in prostate glands larger than 30 mL and a first-line therapy in glands over 80 mL. To date, no data are available whether Aquablation is non-inferior compared with HoLEP in the treatment of patients with medium-to-large-sized prostates regarding safety and efficacy. METHODS AND ANALYSIS: This is a prospective, randomised, open-label, non-inferiority clinical trial conducted at a Swiss centre of tertiary care. The primary outcome is assessment of non-inferiority of Aquablation compared with HoLEP in reducing lower urinary tract symptoms due to benign prostatic obstruction measured by the International Prostate Symptom Score (IPSS). Randomisation will be performed using secuTrial, stratifying on age (<70 years, 70+ years) and prostate volume (<100 mL, 100+ mL). Both interventions are performed in an inpatient setting and regular follow-up controls starting 8 weeks after intervention and continuing up to 5 years will be performed. The primary outcome (change in IPSS from baseline to 6 months) will be tested for non-inferiority with a one-sided t-test. Secondary outcomes, such as efficacy parameters, several patient-reported outcome measures, and periprocedural and safety parameters will be described by calculating means or relative frequencies for each treatment group and testing differences with two-sided standard superiority tests. ETHICS AND DISSEMINATION: The study was approved by the local ethics committee (EKOS 2020-02353). Results of the primary endpoint and each of the secondary endpoints will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04560907).