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
| Autor: | Gautier Müllhaupt, Patrick Betschart, Daniel S. Engeler, Hans-Peter Schmid, Sabine Güsewell, Valentin Zumstein, Dominik Abt |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Urology Enucleation 030232 urology & nephrology Prostatic Hyperplasia Lasers Solid-State surgery 03 medical and health sciences 0302 clinical medicine Lower urinary tract symptoms Prostate medicine Clinical endpoint Humans adult urology Prospective Studies Transurethral resection of the prostate Aged Randomized Controlled Trials as Topic business.industry Transurethral Resection of Prostate General Medicine Hyperplasia medicine.disease Clinical trial medicine.anatomical_structure Treatment Outcome 030220 oncology & carcinogenesis Medicine International Prostate Symptom Score Laser Therapy business prostate disease |
| Zdroj: | BMJ Open BMJ Open, Vol 11, Iss 5 (2021) |
| ISSN: | 2044-6055 |
| Popis: | IntroductionA 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 cm3.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 analysisThis 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 (Ethics and disseminationThe 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 numberClinicalTrials.gov Registry (NCT04560907). |
| Databáze: | OpenAIRE |
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