Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03938194 |
| Other study ID # |
CRE 2019.043 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 25, 2019 |
| Est. completion date |
October 21, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
