Holmium laser ablation of the prostate (HoLAP) with moses technology for the surgical treatment of benign prostatic hyperplasia

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 (<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 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).

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Transurethral High Power (80W) Potassium-Titanyl-Phosphase (KTP) Laser Vapourisation of the Prostate Compared with Holmium Laser Ablation of the Prostate: A Single Centre Randomised Controlled Trial in Patients with Obst. Benign Prostatic Hyperplasia

http://isrctn.org/> ◽

10.1186/isrctn14776501 ◽

2013 ◽

Author(s):

Ranjan Thilagarajah

Keyword(s):

Benign Prostatic Hyperplasia ◽

Laser Ablation ◽

Randomised Controlled Trial ◽

High Power ◽

Controlled Trial ◽

Prostatic Hyperplasia ◽

Holmium Laser ◽

Ktp Laser ◽

Single Centre ◽

Randomised Controlled

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V876: Holmium Laser Enucleation of the Prostate (HOLEP) Following Failed Laser Ablation of the Prostate for the Treatment of Benign Prostatic Hyperplasia (BPH)

The Journal of Urology ◽

10.1016/s0022-5347(18)32167-0 ◽

2007 ◽

Vol 177 (4S) ◽

pp. 291-291

Author(s):

Nicole L. Miller ◽

Mitchell R. Humphreys ◽

James E. Lingeman

Keyword(s):

Benign Prostatic Hyperplasia ◽

Laser Ablation ◽

Prostatic Hyperplasia ◽

Holmium Laser ◽

Laser Enucleation ◽

Holmium Laser Enucleation

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Evaluation of mid-term results of bipolar transurethral resection in the treatment of benign prostatic hyperplasia

World Ecology Journal ◽

10.25726/nm.2019.77.26.001 ◽

2018 ◽

pp. 1-9

Author(s):

А.С. Векильян

Keyword(s):

Surgical Treatment ◽

Benign Prostatic Hyperplasia ◽

Blood Loss ◽

Endoscopic Surgery ◽

Transurethral Resection ◽

Operating Time ◽

Clinical Results ◽

Massive Bleeding ◽

Prostatic Hyperplasia ◽

Surgical Methods

Представлены клинические результаты хирургического лечения доброкачественной гиперплазии предстательной железы (ДГПЖ) объемом до 100 см3 методом биполярной трансуретральной резекции простаты (БТУР -74 пациента) в сравнении с открытой чреспузырной простатэктомией (ОПЭ - 96 пациентов), ранее применявшейся для подобных клинических случаев в урологической клинике "Железнодорожной больницы" г. Волгоград. При статистически равном операционном времени обоих хирургических методов для БТУР отмечено существенное снижение интраоперационной кровопотери, сроков послеоперационной катетеризации и пребывания в стационаре, минимальная частота геморрагических и инфекционно-воспалительных осложнений. Наблюдение за урологическим статусом пациентов в течение первого послеоперационного года показало одинаковую клиническую эффективность сравниваемых хирургических методов. Значительное снижение объема кровопотери в ходе операции БТУР можно считать большим достижением, поскольку улучшение видимости в зоне хирургического вмешательства позволяет оптимизировать гемостаз, предотвратить массивные кровотечения как во время, так и после операции, сократить сроки послеоперационной катетеризации мочевого пузыря, что в свою очередь, снижает частоту развития инфекционно-воспалительных осложнений. Более быстрое восстановление пациентов после эндоскопических операций имеет медико-социальное и экономическое значение, поскольку минимальное количество послеоперационных осложнений и сокращение сроков госпитализации позволяет существенно снизить затраты на лечение и быстрее нормализовать качество жизни пациентов. Полученные результаты демонстрируют перспективность внедрения биполярных методов эндоскопических операций для лечения ДГПЖ в хирургическую практику урологических стационаров в целях повышения безопасности оперативного лечения и экономии затрат на госпитализацию. The clinical results of surgical treatment of benign prostatic hyperplasia (BPH) up to 100 cm3 by bipolar transurethral resection of the prostate (BTUR - 74 patients) in comparison with open transvesical prostatectomy (OPE - 96 patients), previously used for such clinical cases in the urological clinic "Railway hospital" in Volgograd are presented. With statistically equal operating time of both surgical methods, there was a significant decrease in intraoperative blood loss, the terms of postoperative catheterization and hospital stay, the minimum frequency of hemorrhagic and infectious-inflammatory complications. Observation of the urological status of patients during the first postoperative year showed the same clinical efficacy of the compared surgical methods. A significant reduction in the volume of blood loss during the operation, can be considered a great achievement, since the improvement of visibility in the area of surgical intervention allows to optimize the hemostasis, to prevent massive bleeding during and after surgery, to reduce the duration of postoperative bladder catheterization, which, in turn, reduces the incidence of infectious-inflammatory complications. Faster recovery of patients after endoscopic surgery of medical,social and economic importance, as the minimum number of postoperative complications and reduction of hospitalization can significantly reduce the cost of treatment and quickly normalize the quality of life of patients. The results demonstrate the prospects of the introduction of bipolar methods of endoscopic surgery for the treatment of BPH in the surgical practice of urological hospitals in order to improve the safety of surgical treatment and save costs for hospitalization.

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