Clinical trial NCT04801381: WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia
Official title: WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80-180ml) in Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Keywords: Aquablation therapy
Laserenucleation
HoLEP
ThuLEP
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: PROCEPT BioRobotics
First posted: 2021-03-17
Enrollment: 202
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized and non-randomized trial
Primary purpose: TREATMENT

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).

Eligibility 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:

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

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: 3 months after index procedure
measure: Primary Safety Endpoint
timeFrame: Through 3 months after index procedure
Secondary outcomes:
measure: Change in IPSS
timeFrame: 1,6,12,24,36,48 and 60 months after index procedure
measure: Change in IIEF 5/SHIM
timeFrame: 3,6,12,24,36,48 and 60 months after index procedure
measure: Change in MSHQ-EjD-SF
timeFrame: 3,6,12,24,36,48 and 60 months after index procedure
measure: Change in Dysuria Questionnaire
timeFrame: 1,3,6,12,24,36,48 and 60 months after index procedure
measure: Change in ICIQ-UI-SF
timeFrame: 1,3,6,12, 24,36,48 and 60 months after index procedure
measure: Post void residual urine
timeFrame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
measure: Qmax, Uroflowmetry
timeFrame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
measure: Prostate volume reduction
timeFrame: comparison of Visit 5 (3 months) and visit 1 (baseline)
measure: Number of re-interventions
timeFrame: Through 60 months after index procedure
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Department of Urology, University Hospital Freiburg
state: Baden-Württemberg
city: Bochum
country: Germany
facility: Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte
state: NRW
city: Bonn
country: Germany
facility: Department of Urology, University Hospital Bonn
state: NRW
city: London
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospital
Study officials:
affiliation: Department of Urology, University of Bonn
name: Manuel Ritter, Univ.-Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: