The WATER Study
Research type
Research Study
Full title
The WATER Study: Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue
IRAS ID
186118
Contact name
Steve Fermi
Contact email
Sponsor organisation
Procept Biorobotics
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 1 months, 26 days
Research summary
The WATER study is a prospective, multicentre, randomised study comparing Aquablation of the prostate using the AQUABEAM System and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms.
The clinical investigation will compare the safety and effectiveness of the AQUABEAM System versus TURP in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80 years of age. Approximately 270 patients will be randomized worldwide, to undergo either Aquablation or TURP (approximately 180 patients Aquablation, 90 patients TURP).
The screening period will last for up to 90 days and if patients are eligible they will be randomised to undergo either Aquablation or the TURP procedure. The patients will not be told which treatment they received until the 6-month follow up visit has been completed, so the effect of the treatments can be compared without any bias.
Patients will be contacted by telephone approximately 1 week after their procedure and will be asked to visit the hospital clinic for follow up visits at 1, 3, 6, 12, 24 and 36 months. The study will therefore last for up to 3 years after the procedure.
Study participants will undertake various study tests and examinations including blood and urine tests, urological and digital rectal examinations, cystourethroscopy and trans-rectal ultrasound. Patients will also be asked to answer questionnaires to record information about their quality of life, the level of pain experienced, presence of urinary continence and male sexual health and function.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/1637
Date of REC Opinion
20 Nov 2015
REC opinion
Further Information Favourable Opinion