N40
Conditions
Interventions
Group 1: Aquablation therapy (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA): Computer-assisted transurethral ablation of prostate tissue using a high-pressure water jet. Subseq
Sponsors
Klinik und Poliklinik für Urologie Universitätsklinikum Bonn
Eligibility
Sex/Gender
Male
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 45 – 80 years 2. International Prostate Symptom Score (IPSS) = 8 3. Prostate size (measurement by transrectal ultrasound): 80 – 180 mL 4. Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (Benign Prostatic Hyperplasia) 5. Patient is mentally capable and willing to sign a study-specific consent form 6. Subjects with the ability to follow study instructions and likely to attend and complete all required visits 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Body mass index = 42 2. Suspected or history of prostate cancer 3. Suspected or history of bladder cancer 4. Bladder stone 5. Indwelling catheter for more than 3 months before baseline 6. Active urinary tract infection 7. History of urethral stricture or bladder neck stenosis 8. Damage of the external urethral sphincter 9. Previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis) 10. Use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ASS 100mg/d). 11. Contraindications for general and spinal anaesthesia 12. The investigator considers a pre-existing condition or the subject's life circumstances to be problematic for the conduct of the study and the completion of the follow-up investigations 13. Subject is unwilling to accept a blood transfusion if required 14. Subject is not able to give consent 15. Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial 16. Simultaneously participation in another clinical trial in the field of urology 17. Known or persistent abuse of medication, drugs or alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The trial includes both a primary efficacy and a primary safety endpoint. Primary Efficacy Endpoint The primary endpoint is defined as IPSS (International Prostate Symptom Score) change 3 months after surgery. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in IPSS (International Prostate Symptom Score) (Visits 4-11, 1st-60th month) 2. Change in IIEF 5 (International Index of Erectile Function) 3. Change in MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form)(Visit 5-11, 3rd to 60th month) 4. Change in Dysuria Questionnaire (Visits 4-11, 1st-60th month) 5. Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) (Visits 4-11, 1st-60th month) 6. Reduction of Post void residual urine (Visits 3,5,6,7,9) 7. Changes Qmax (Uroflowmetry)(Visits 3,5,6,7,9) 8. Prostate volume reduction (comparison of visit 5 and visit 1) 9. Number of re-interventions: defined as need for additional tissue resection following the index procedure due to BPH. | — |
Countries
Germany
Contacts
Public ContactJohannes Stein
Klinik und Poliklinik für Urologie Universitätsklinikum Bonn
Outcome results
None listed