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NCT Number: NCT04801381

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, University Hospital Freiburg, Freiburg im Breisgau, Baden-Wurttemberg, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Aquablation therapy

Procedure

Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA

Transurethral laser enucleation

Procedure

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).

Primary outcomes

  1. Primary Efficacy Endpoint

    Time frame: 3 months after index procedure

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

  2. 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.

Secondary outcomes

  1. Change in IPSS

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

    Change in IPSS (International Prostate Symptom Score)

  2. Change in IIEF 5/SHIM

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

    Change in IIEF5/SHIM (International Index of Erectile Function)

  3. Change in MSHQ-EjD-SF

    Time frame: 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)

  4. Change in Dysuria Questionnaire

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

    Change in Dysuria Questionnaire

  5. Change in ICIQ-UI-SF

    Time frame: 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)

  6. Post void residual urine

    Time frame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure

    Reduction of Post void residual urine

  7. Qmax, Uroflowmetry

    Time frame: day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure

    Changes of maximum flow rate (Qmax) measured by Uroflowmetry

  8. Prostate volume reduction

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

    Prostate volume reduction

  9. Number of re-interventions

    Time frame: Through 60 months after index procedure

    Number of re-interventions defined as need for additional tissue resection following the index procedure due to BPH.

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Collaborators

  • PROCEPT BioRobotics

Registry information

Official study title

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

Acronym: WATER III

Important dates

Study start
2020
Primary completion
2025
Study completion
2029
First posted
Mar 17, 2021
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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