Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
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.
Interventions
None listed
Sponsors
PROCEPT BioRobotics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
45 Years to 85 Years
Inclusion criteria
1. Subject was randomized and received treatment in the WATER Study. 2. Subject is mentally capable and willing to sign a study-specific informed consent form 3. 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 2. Participating in another investigational study that could affect responses to the study assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term effectiveness as measured by IPSS at 60 months | 60 months following original surgical intervention | International Prostate Symptom Score at 60 months as compared to baseline |
| Long-term safety as measured by adverse events at 60 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reoperation or Re-intervention at 60 months | 60 months | Reoperation or Re-intervention at 60 months |
| IPSS-QoL at 60 months | 60 months | International Prostate Symptom Score Quality of Life sub-score |
| Erectile function at 60 months | 60 months | IIEF-15 score |
| PVR at 60 months | 60 months | Post-void residual urine test |
| Qmax at 60 months | 60 months | Uroflowmetry measurement of voided urine (in milliliters) per unit of time (in seconds) |
| MSHQ-EjD at 60 months | 60 months | Assessment of ejaculatory function/dysfunction |
Countries
United Kingdom
Contacts
Primary ContactAngela Lee
Outcome results
None listed