UK POST WATER Study
Research type
Research Study
Full title
UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue
IRAS ID
293279
Contact name
Neil Barber
Contact email
Sponsor organisation
Procept BioRobotics
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
The UK POST WATER Study is a continued follow-up for patients previously enrolled in the WATER Study, where they were either treated with the Aquabeam System or TURP for treatment of Benign Prostatic Hyperplasia (BPH), with lower urinary tract symptoms (LUTS). The purpose of this study is to collect data at the time point of 5 years following the original study surgery in order to determine ongoing effectiveness of the procedures and health status of the participants.
The previously-run WATER Study was extended to 5-year follow-up by the manufacturer of the study device and the Sponsor of the study to collect additional procedure effectiveness and other outcome data. Since the UK sites enrolled subjects in the WATER study quite early, when the study extension was ready to execute for the rest of the sites in New Zealand, Australia, and United States, all the UK sites have already been in the middle of study close-out activities. Due to the timing of the extension, it was determined that the WATER Study 5-year follow up data collection at the UK sites will be carried out under a new study ID: the UK POST-WATER Study.
The 5-year follow-up data collected in the UK POST-WATER Study will be analysed with the remaining WATER subjects enrolled outside of the UK in the WATER Study protocol revision H.
Eligibility for the UK POST WATER Study is the completion of 3-year follow-up in the previously-run WATER Study, and willingness to participate in one additional visit at 60 months (5 years).
Summary of Results
The purpose of this study was to compare the long-term results of the study device (meaning, the AQUABEAM Robotic System) with a standard surgical procedure called Transurethral Resection of the Prostate, or TURP – at 5 years after the surgery. Patient who agreed to participate in UK POST WATER Study were seen at one visit at year 5 from the initial treatment in the WATER study.
The data from this study was combined with data from the patients who continued to take part in the WATER study in the United States, New Zealand, and Australia – so that all the data could be analysed together.
Patients treated with the AQUABEAM device and TURP procedure were reviewed to determine how they compared in three main areas: urinary symptoms, improvement in urinary flow, and the risk of needing an additional BHP surgery.
The results showed:• Urinary symptoms: Overall, both groups showed a reduction in symptoms associated with BPH at five years, with neither group being better than the other. In men with larger prostates, however, the reduction in symptoms was greater in the Aquablation group than the TURP group.
• Urinary flow improvement: Both groups showed an improved urinary flow at one month after the initial surgery that was maintained over five years of follow-up.
• Need for additional BPH treatment: At 5 years, 6% of patients treated with Aquablation needed additional BPH treatment (surgery or medication), compared to over 12% of patients who had TURP.
The results of the study are published in the below article written by the study investigators. In that publication, the conclusion was that the improvement in health outcomes from Aquablation surgery outweighed improvements seen with TURP.
P. J. Gilling et al., “Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH,” Can J Urol, vol. 29, no. 1, pp. 10960–10968, Feb. 2022.
REC name
South East Scotland REC 01
REC reference
21/SS/0006
Date of REC Opinion
29 Jan 2021
REC opinion
Further Information Favourable Opinion