UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

PROCEPT BioRobotics

Status: Unknown

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Study type: Observational

Funder types: Industry

Identifiers

NCT04658056

CSP0002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 46 estimated patients

Sex: Male

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

46 participants in 2 patient groups

WATER AQUABEAM Robotic System cohort

Description:

WATER Study subjects previously-treated with Aquablation of the prostate with the AQUABEAM Robotic System for lower urinary tract symptoms associated with BPH.

WATER TURPS cohort

Description:

WATER Study subjects previously-treated with standard transurethral resection of the prostate (TURP) for lower urinary tract symptoms associated with BPH.