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Active, not recruitingNCT04801381WATER IIIUpdated Feb 6, 2025

WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia

An interventional study of Aquablation therapy and Transurethral laser enucleation in BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms, sponsored by University of Bonn. Active, not recruiting at 5 sites in 2 countries. Open to male participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by University of Bonn · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
Male
01

Study 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 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).

02

Conditions studied

  • BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Keywords

  • Aquablation therapy
  • Laserenucleation
  • HoLEP
  • ThuLEP
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 202 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

University of Bonn is the lead sponsor of 36 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
202 participants (actual)

Study arms

  • Active comparator
    Aquablation therapy

    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).

    Procedure: Aquablation therapy

  • Active comparator
    Transurethral laser enucleation

    Transurethral laser enucleation of the prostate using thulium laser (ThuLEP) or holmium laser (HoLEP).

    Procedure: Transurethral laser enucleation

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).

06

What researchers measure

Primary outcomes

  1. Primary Efficacy Endpoint

    Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change

    Time frame: 3 months after index procedure

  2. 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

Secondary outcomes

  1. Change in IPSS

    Change in IPSS (International Prostate Symptom Score)

    Time frame: 1,6,12,24,36,48 and 60 months after index procedure

  2. 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

  3. 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

  4. Change in Dysuria Questionnaire

    Change in Dysuria Questionnaire

    Time frame: 1,3,6,12,24,36,48 and 60 months after index procedure

  5. Change in ICIQ-UI-SF

    Change in ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)

    Time frame: 1,3,6,12, 24,36,48 and 60 months after index procedure

  6. 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

  7. 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

  8. Prostate volume reduction

    Prostate volume reduction

    Time frame: comparison of Visit 5 (3 months) and visit 1 (baseline)

  9. 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

07

Study locations

5 sites
  • Department of Urology, University Hospital Freiburg
    Freiburg, Baden-Württemberg 79106, Germany
  • Department of Urology, Augusta-Kranken-Anstalt, Bochum Mitte
    Bochum, NRW 44791, Germany
  • Department of Urology, University Hospital Bonn
    Bonn, NRW 53127, Germany
  • Frimley Health NHS Foundation Trust
    London, United Kingdom
  • Guy's and St. Thomas' Hospital
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04801381
Lead sponsor
University of Bonn
Collaborators
PROCEPT BioRobotics
Responsible party
Manuel Ritter (Univ.-Prof. Dr. med. Manuel Ritter, University of Bonn) — Principal investigator
First posted
Mar 17, 2021
Start date
Dec 16, 2020
Primary completion
Jan 16, 2025
Completion
Oct 2029 (estimated)
Last update
Feb 6, 2025

Study contacts

Manuel Ritter, Univ.-Prof. Dr. med.
principal investigator · Department of Urology, University of Bonn

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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