BPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsWATER IIINCT04801381
WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia
A study testing Aquablation therapy and Transurethral laser enucleation in people with BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms, run by University of Bonn at 5 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
- What is being tested?
- Aquablation therapy and Transurethral laser enucleation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 16 Dec 2020to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 45 - 80 years
- International Prostate Symptom Score (IPSS) ≥ 8
- Prostate size (measurement by transrectal ultrasound): 80 - 180 mL
- Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (Benign Prostatic Hyperplasia)
- Patient is mentally capable and willing to sign a study-specific consent form
- Subjects with the ability to follow study instructions and likely to attend and complete all required visits
- Written informed consent
Who cannot join
- Body mass index ≥ 42
- Suspected or history of prostate cancer
- Suspected or history of bladder cancer
- Bladder stone
- Indwelling catheter for more than 3 months before baseline
- Active urinary tract infection
Show all 17Show fewer
- History of urethral stricture or bladder neck stenosis
- Damage of the external urethral sphincter
- Previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis)
- Use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ASS 100mg/d).
- Contraindications for general and spinal anaesthesia
- 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
- Subject is unwilling to accept a blood transfusion if required
- Subject is not able to give consent
- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- Simultaneously participation in another clinical trial in the field of urology
- Known or persistent abuse of medication, drugs or alcohol
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte
Bochum, North Rhine-Westphalia, 44791
Department of Urology, University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Department of Urology, University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
United Kingdom2 sites
Frimley Health NHS Foundation Trust
London
Guy's and St. Thomas' Hospital
London
About this study
Official title: WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80-180ml) in Benign Prostatic Hyperplasia
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).
Read the 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).
- Being tested
- Aquablation therapy, Transurethral laser enucleation
- Keywords
- Aquablation therapy, Laserenucleation, HoLEP, ThuLEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquablation therapyProcedure or surgery
Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
Transurethral laser enucleationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Aquablation therapy | Active comparator | Aquablation therapy: Computer-assisted transurethral ablation of prostate tissue using a high-pressure water jet. Subsequent removal of residual ablated tissue at the bladder neck and haemostasis by transurethral electroresection (TUR). Receives: Procedure: Aquablation therapy |
| Transurethral laser enucleation | Active comparator | Transurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP). Receives: Procedure: Transurethral laser enucleation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change
Measured: 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.
Measured: Through 3 months after index procedure
Secondary outcomes (9)
Change in IPSS
Change in IPSS (International Prostate Symptom Score)
Measured: 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)
Measured: 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)
Measured: 3,6,12,24,36,48 and 60 months after index procedure
Change in Dysuria Questionnaire
Change in Dysuria Questionnaire
Measured: 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)
Measured: 1,3,6,12, 24,36,48 and 60 months after index procedure
Post void residual urine
Reduction of Post void residual urine
Measured: 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
Measured: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Prostate volume reduction
Prostate volume reduction
Measured: 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.
Measured: Through 60 months after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start16 Dec 2020
- Primary completion16 Jan 2025
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized and non-randomized trial
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- PROCEPT BioRobotics
- Responsible party
- Principal investigator, Manuel Ritter, University of Bonn
- Investigators
- Manuel Ritter, Univ.-Prof. Dr. med., Principal investigator, Department of Urology, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801381
- Sponsor's protocol ID
- URO-202001
- Acronym
- WATER III
- Status last verified
- Feb 2025
- First submitted
- 10 Mar 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80-180ml) in Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04801381
- Acronym / sponsor ID
- WATER III / URO-202001
- Keywords
- Aquablation therapy, Laserenucleation, HoLEP, ThuLEP
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- PROCEPT BioRobotics
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- Oct 2029 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized and non-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Aquablation therapy | Active comparator | Procedure: Aquablation therapyAquablation therapy: Computer-assisted transurethral ablation of prostate tissue using a high-pressure water jet. Subsequent removal of residual ablated tissue at the bladder neck and haemostasis by transurethral electroresection (TUR). |
| Transurethral laser enucleation | Active comparator | Procedure: Transurethral laser enucleationTransurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 45 - 80 years
- International Prostate Symptom Score (IPSS) ≥ 8
- Prostate size (measurement by transrectal ultrasound): 80 - 180 mL
- Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (Benign Prostatic Hyperplasia)
- Patient is mentally capable and willing to sign a study-specific consent form
Key exclusion criteria (17 listed)
- Body mass index ≥ 42
- Suspected or history of prostate cancer
- Suspected or history of bladder cancer
- Bladder stone
- Indwelling catheter for more than 3 months before baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquablation therapyAquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA | Procedure or surgery | Aquablation therapy |
| Transurethral laser enucleationTransurethral laser enucleation is performed according to the standard established at the respective test center. Included laser techniques: Holmium laser (HoLEP) and Thulium laser (ThuLEP). | Procedure or surgery | Transurethral laser enucleation |
Primary outcome
Primary Efficacy Endpoint
Time frame: 3 months after index procedure
Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change
Primary Safety Endpoint
Time frame: 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.
9 secondary outcomes
Change in IPSS
Time frame: 1,6,12,24,36,48 and 60 months after index procedure
Change in IIEF 5/SHIM
Time frame: 3,6,12,24,36,48 and 60 months after index procedure
Change in MSHQ-EjD-SF
Time frame: 3,6,12,24,36,48 and 60 months after index procedure
Change in Dysuria Questionnaire
Time frame: 1,3,6,12,24,36,48 and 60 months after index procedure
Change in ICIQ-UI-SF
Time frame: 1,3,6,12, 24,36,48 and 60 months after index procedure
Post void residual urine
Time frame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Qmax, Uroflowmetry
Time frame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure
Prostate volume reduction
Time frame: comparison of Visit 5 (3 months) and visit 1 (baseline)
Number of re-interventions
Time frame: Through 60 months after index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Ritter, Univ.-Prof. Dr. med. principal investigator
Department of Urology, University of Bonn
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquablation therapy and Transurethral laser enucleation in people with BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms, run by University of Bonn at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: 3 months after index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.