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

The UK POST WATERStudy: UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

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).

Study Overview

• Status: Unknown
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

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 Type: Observational
• Enrollment (Anticipated): 46

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Camberley, Surrey, United Kingdom, GU16 7UJ
      • Frimley Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The target patient population is subjects who were enrolled in the WATER Study (with symptomatic BPH) who were randomized to treatment with either the Aquablation procedure or TURP.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
WATER AQUABEAM Robotic System cohort; 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; WATER Study subjects previously-treated with standard transurethral resection of the prostate (TURP) for lower urinary tract symptoms associated with BPH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term effectiveness as measured by IPSS at 60 months	International Prostate Symptom Score at 60 months as compared to baseline	60 months following original surgical intervention
Long-term safety as measured by adverse events at 60 months	The proportion of subjects with adverse events classified as Clavien-Dindo Grade 2 or higher or any grade 1 event resulting in persistent disability	60 months following original surgical intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation or Re-intervention at 60 months	Reoperation or Re-intervention at 60 months	60 months
IPSS-QoL at 60 months	International Prostate Symptom Score Quality of Life sub-score	60 months
Qmax at 60 months	Uroflowmetry measurement of voided urine (in milliliters) per unit of time (in seconds)	60 months
PVR at 60 months	Post-void residual urine test	60 months
Erectile function at 60 months	IIEF-15 score	60 months
MSHQ-EjD at 60 months	Assessment of ejaculatory function/dysfunction	60 months

Collaborators and Investigators

• Sponsor: PROCEPT BioRobotics
• Investigators: Principal Investigator: Claus Roehrborn, MD, UT Southwestern Medical; Principal Investigator: Peter Gilling, MD, Tauranga Urology Research Limited

Publications and helpful links

General Publications

• Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial. Can J Urol. 2020 Feb;27(1):10072-10079.
• Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, Roehrborn C. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. Adv Ther. 2019 Jun;36(6):1326-1336. doi: 10.1007/s12325-019-00952-3. Epub 2019 Apr 26.
• Pimentel MA, Yassaie O, Gilling P. Urodynamic Outcomes After Aquablation. Urology. 2019 Apr;126:165-170. doi: 10.1016/j.urology.2019.01.020. Epub 2019 Feb 2.
• Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Roehrborn C. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urology. 2019 Mar;125:169-173. doi: 10.1016/j.urology.2018.12.002. Epub 2018 Dec 12.
• Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc). Adv Ther. 2018 Jun;35(6):832-838. doi: 10.1007/s12325-018-0722-0. Epub 2018 Jun 5.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): February 1, 2022

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: CSP0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No