WATERIII
Research type
Research Study
Full title
WATER III: A Randomized, Controlled Trial of Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80 - 180mL) in Benign Prostatic Hyperplasia
IRAS ID
318223
Contact name
Neil Barber
Contact email
Sponsor organisation
UK Bonn
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Benign prostatic hyperplasia (BPH), or enlargement of the prostate due to benign growth of glandular tissue, is a very common disease of older men. Prostatic tissue may compress the urethral canal, causing partial or sometimes complete obstruction of the prostatic urethra, which interferes with the normal flow of urine. Symptoms of BPH include urinary hesitancy, frequent urination, dysuria, increased risk of urinary tract infections and urinary retention.
Therapy for BPH includes medication and various surgical approaches.
Surgical therapy of BPH has continuously evolved in recent years. Transurethral resection of the prostate (TUR-P) is the current gold standard for the treatment of small to medium prostate volumes but it carries risks, including bleeding, clot retention/colic, bladder wall injury, hyponatremia (water intoxication), bladder neck contracture, urinary incontinence, retrograde ejaculation, and erectile dysfunction.
For large prostate volumes above 80 mL, transurethral laser enucleation is considered as the current reference standard for minimal invasive treatment of large prostate volumes.One of the latest technologies for transurethral prostate is the use of the AQUABEAM Robotic System intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms. Clinical experience demonstrates that the mechanism of action, controlled delivery of high-velocity saline stream, will potentially reduce complications including sexual dysfunction and result in an effective and rapid treatment option for patients with symptomatic BPH.
The WATER III Study, being conducted at a NHS centre in the UK as well as centres in Germany, is a randomized post-market registry. The objective is a comparative analysis of the safety and efficacy of Aquablation therapy and transurethral laser enucleation as reference standard for minimal-invasive treatment of BPH with large prostates (80-180 mL).Up to 200 subjects globally with symptomatic BPH and who are suitable for surgical treatment will be included in the study. Eligibility is determined by prostate size as measured by ultrasound, and other clinical factors. Each subject is followed postoperatively for 5 years.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
22/LO/0893
Date of REC Opinion
6 Feb 2023
REC opinion
Further Information Favourable Opinion