BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Conditions
Keywords
Aquablation therapy, Laserenucleation, HoLEP, ThuLEP
Brief summary
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).
Detailed description
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).
Interventions
PROCEDUREAquablation therapy
Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
PROCEDURETransurethral laser enucleation
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).
Sponsors
PROCEPT BioRobotics
University of Bonn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized and non-randomized trial
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
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
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 | Description |
|---|---|---|
| Primary Efficacy Endpoint | 3 months after index procedure | Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change |
| Primary Safety Endpoint | Through 3 months after index procedure | 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 | Description |
|---|---|---|
| Change in MSHQ-EjD-SF | 3,6,12,24,36,48 and 60 months after index procedure | Change in MSHQ-EjD-SF (Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form) |
| Change in Dysuria Questionnaire | 1,3,6,12,24,36,48 and 60 months after index procedure | Change in Dysuria Questionnaire |
| Change in ICIQ-UI-SF | 1,3,6,12, 24,36,48 and 60 months after index procedure | Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) |
| Change in IPSS | 1,6,12,24,36,48 and 60 months after index procedure | Change in IPSS (International Prostate Symptom Score) |
| Qmax, Uroflowmetry | day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure | Changes of maximum flow rate (Qmax) measured by Uroflowmetry |
| Prostate volume reduction | comparison of Visit 5 (3 months) and visit 1 (baseline) | Prostate volume reduction |
| Number of re-interventions | Through 60 months after index procedure | Number of re-interventions defined as need for additional tissue resection following the index procedure due to BPH. |
| Post void residual urine | day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure | Reduction of Post void residual urine |
| Change in IIEF 5/SHIM | 3,6,12,24,36,48 and 60 months after index procedure | Change in IIEF5/SHIM (International Index of Erectile Function) |
Countries
Germany, United Kingdom
Outcome results
None listed