Comparative analysis of efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) and transurethral laser enucleation as surgical therapy for benign prostatic hyperplasia with large prostates (80-180ml).
Prospective randomized and non-randomized cohort, two-arm multicenter trial two arm multicenter trial to evaluate the efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) compared to transurethral laser enucleation - the current reference standard of minimal invasive therapy for benign prostatic hyperplasia in large prostates (80-180ml).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
Transurethral laser enucleation is performed according to the standard established at the respective test center. Included laser techniques: Holmium laser (HoLEP) and Thulium laser (ThuLEP).
Department of Urology, University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte
Bochum, North Rhine-Westphalia, Germany
Department of Urology, University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany
Frimley Health NHS Foundation Trust
London, United Kingdom
Primary Efficacy Endpoint
Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change
Time frame: 3 months after index procedure
Primary Safety Endpoint
Primary safety endpoint is defined as the occurrence of an Adverse Event rated by the investigator as related or unrelated to the study procedure, classified as Clavien Dindo grade 2 or higher or any grade 1 event resulting in persistent disability, such as ejaculatory or erectile dysfunction or incontinence, as evidenced through 3 months after treatment.
Time frame: Through 3 months after index procedure
Change in IPSS
Change in IPSS (International Prostate Symptom Score)
Time frame: 1,6,12,24,36,48 and 60 months after index procedure
Change in IIEF 5/SHIM
Change in IIEF5/SHIM (International Index of Erectile Function)
Time frame: 3,6,12,24,36,48 and 60 months after index procedure
Change in MSHQ-EjD-SF
Change in MSHQ-EjD-SF (Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form)
Time frame: 3,6,12,24,36,48 and 60 months after index procedure
Change in Dysuria Questionnaire
Change in Dysuria Questionnaire
Time frame: 1,3,6,12,24,36,48 and 60 months after index procedure
Change in ICIQ-UI-SF
Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)
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Guy's and St. Thomas' Hospital
London, United Kingdom
Time frame: 1,3,6,12, 24,36,48 and 60 months after index procedure
Post void residual urine
Reduction of Post void residual urine
Time frame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Qmax, Uroflowmetry
Changes of maximum flow rate (Qmax) measured by Uroflowmetry
Time frame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Prostate volume reduction
Prostate volume reduction
Time frame: comparison of Visit 5 (3 months) and visit 1 (baseline)
Number of re-interventions
Number of re-interventions defined as need for additional tissue resection following the index procedure due to BPH.
Time frame: Through 60 months after index procedure