The UK POST WATERStudy: UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Long-term safety as measured by adverse events at 60 months
Study Overview
Brief Summary
A post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS).
Detailed Description
The study is a post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS). In POST WATER, up to 46 WATER Study subjects in the United Kingdom who were active on the study at 36 months will be invited to participate, across 3 clinical study sites in England and Wales. The study will consist of one follow-up time-point at 60 months (5 years) from the time of initial WATER Study treatment date.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject was randomized and received treatment in the WATER Study.
- •Subject is mentally capable and willing to sign a study-specific informed consent form
- •Subject is willing and able to comply with all study requirements
Exclusion Criteria
- •Dementia or psychiatric condition that prevents the participant from completing required follow up
- •Participating in another investigational study that could affect responses to the study assessments
Outcomes
Primary Outcomes
Long-term safety as measured by adverse events at 60 months
Time Frame: 60 months following original surgical intervention
The proportion of subjects with adverse events classified as Clavien-Dindo Grade 2 or higher or any grade 1 event resulting in persistent disability
Long-term effectiveness as measured by IPSS at 60 months
Time Frame: 60 months following original surgical intervention
International Prostate Symptom Score at 60 months as compared to baseline
Secondary Outcomes
No secondary outcomes reported