Waterjet Prostate Ablation

Image-guided Robot-assisted Waterjet Ablation of the Prostate for Patients With Retention of Urine Due to Benign Prostatic Obstruction

Introduction Men with enlarged prostates commonly experience lower urinary tract symptoms and may go on to develop complications such as acute urinary retention (AUR). Surgery is the standard treatment option required to remove the enlarged prostates and to rectify such complications.

Transurethral resection of prostate (TURP) was first performed over 80 years ago and is still regarded as the "gold standard" for the treatment of benign prostatic enlargement (BPE) in prostates between 30 and 80ml. While TURP results in an improvement in symptoms, perioperative morbidity and long-term complications can include postoperative bleeding, urinary retention, incontinence, urethral strictures, erectile dysfunction, and ejaculatory dysfunction. Aquablation, a novel minimally invasive water ablation therapy combining image guidance and robotics (AQUABEAM®, Procept BioRobotics, Redwood Shores, CA, USA) for the targeted and heatfree removal of prostate tissue is one of the efforts in the development of new technology in recent years to replicate the effectiveness of TURP and at the same time with an improved safety profile. In this study, investigators plan to evaluate the feasibility and safety of Aquablation in the management of AUR secondary to BPE.

Method 20 participants are expected in this study. After patients consent to participate in the study, they will go through Aquablation under general anaesthesia or spinal anaesthesia. The ablation is delivered by transurethral means. After the procedure, subject is expected to go home on the following day. Subject will be assessed 3 months and 6 months after the procedure. Follow-up assessment includes blood tests, prostate ultrasound and urodynamic study.

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Aquablation

Detailed Description

Benign prostatic enlargement (BPE) is a non-malignant growth of the prostate gland that can lead to a range of lower urinary tract symptoms (LUTS), and in some cases eventually leading to retention of urine. In patients failing to wean off catheter after retention of urine due to BPE, surgical intervention is the standard treatment.

Surgical intervention options have evolved from electrosurgical resection to the use of lasers for enucleation and ablation. Transurethral resection of prostate (TURP) was first performed over 80 years ago and is still regarded as the "gold standard" for the treatment of BPE in prostates between 30 and 80ml. While TURP results in a statistically significant improvement in symptoms score and and maximum urinary flow rate (Qmax), perioperative morbidity and long-term complications can include postoperative bleeding, urinary retention, incontinence, urethral strictures, erectile dysfunction, and ejaculatory dysfunction. Aquablation, a novel minimally invasive water ablation therapy combining image guidance and robotics (AQUABEAM®, Procept BioRobotics, Redwood Shores, CA, USA) for the targeted and heat-free removal of prostate tissue is one of the efforts in the development of new technology in recent years to replicate the effectiveness of TURP and at the same time with an improved safety profile. Safety and feasibility of Aquablation in the management of benign prostatic hyperplasia (BPH) have been proven successful in both canine model and human. Since then, two other prospective non-randomized trials demonstrated that the surgical ablation of the prostate using Aquablation had achieved significant and immediate improvement of functional voiding parameters as well as symptomatic improvement. Two randomized controlled trials comparing Aquablation against TURP found that Aquablation had produced a similar improvement in LUTS as TURP, with a better side-effect profile. AQUABEAM® is currently a FDA approved equipment for the ablation of prostate tissue. It is being used in US as well as in Europe and New Zealand.

So far, all studies focused on the application of Aquablation in patients with LUTS only secondary to benign prostatic obstruction (BPO). In this study, investigators plan to evaluate the feasibility and safety of Aquablation in the management of another facet of BPH, which is retention of urine.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Retention of urine refractory to medical treatment

Exclusion Criteria:

• Patients with active urinary tract infection
• Patients with bleeding disorder or on anti-coagulation
• Patients with bladder pathology including bladder stone and bladder cancer
• Patients with urethral stricture
• Patients with neurogenic bladder and/or sphincter abnormalities
• Patients with previous nonpharmacological prostate treatment,
• Prostate cancer
• Fail to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aquablation; Surgery of benign prostatic hyperplasia by waterjet ablation	Procedure: Aquablation; a novel minimally invasive water ablation therapy combining image guidance and robotics for the targeted and heat-free removal of prostate tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wean off Catheter	% success in weaning off catheter	Post operation 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Complications rate after study intervention	Post operation 30 days
International Prostate Symptom Score (IPSS) questionnaire total Score	Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires	Post operation 3 months & 6 months
International Prostate Symptom Score (IPSS) questionnaire QoL Score	Change in quality of life assessed by International Prostate Symptom Score questionnaire (ranges from 0 to 6)	Post operation 3 months & 6 months
International Index of Erectile Function 5 (IIEF-5) questionnaire score	Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25)	Post operation 3 months & 6 months
Overactive bladder symptom score (OABSS) questionnaire total score	Change in total score in Overactive Bladder Symptom Score questionnaire (ranges from 0 - 15)	Post operation 3 months & 6 months
Pain Score	Post-treatment pain score ranges from 1 to 10	Post operation day 1 & 3 months
Change in urodynamic in flowrate	Functional outcome 1: change in urodynamic function assessed by Uroflowmetry	Post operation 3 months
Change in urodynamic in cystometry	Functional outcome 2: change in urodynamic function assessed by cystometrogram (CMG)	Post operation 6 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): May 17, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CRE 2019.043

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