Benign Prostatic HyperplasiaNCT03938194
Waterjet Prostate Ablation
A study testing Aquablation in people with Benign Prostatic Hyperplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Aquablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Apr 2019to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Retention of urine refractory to medical treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Aquablation
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquablationProcedure or surgery
a novel minimally invasive water ablation therapy combining image guidance and robotics for the targeted and heat-free removal of prostate tissue
| Study group | Role | What they receive |
|---|---|---|
| Aquablation | Experimental | Surgery of benign prostatic hyperplasia by waterjet ablation Receives: Procedure: Aquablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wean off Catheter
% success in weaning off catheter
Measured: Post operation 3 days
Secondary outcomes (8)
Complication rate
Complications rate after study intervention
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Post operation 3 months & 6 months
Pain Score
Post-treatment pain score ranges from 1 to 10
Measured: Post operation day 1 & 3 months
Change in urodynamic in flowrate
Functional outcome 1: change in urodynamic function assessed by Uroflowmetry
Measured: Post operation 3 months
Change in urodynamic in cystometry
Functional outcome 2: change in urodynamic function assessed by cystometrogram (CMG)
Measured: Post operation 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start25 Apr 2019
- Primary completion17 May 2021
- Study completion21 Oct 2021
Why it stopped: Equipment is not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Hang Yee, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938194
- Sponsor's protocol ID
- CRE 2019.043
- Status last verified
- Dec 2021
- First submitted
- 23 Apr 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-guided Robot-assisted Waterjet Ablation of the Prostate for Patients With Retention of Urine Due to Benign Prostatic Obstruction
- ClinicalTrials.gov ID
- NCT03938194
- Acronym / sponsor ID
- CRE 2019.043
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Equipment is not available
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquablation | Experimental | Procedure: AquablationSurgery of benign prostatic hyperplasia by waterjet ablation |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Retention of urine refractory to medical treatment
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquablationa novel minimally invasive water ablation therapy combining image guidance and robotics for the targeted and heat-free removal of prostate tissue | Procedure or surgery | Aquablation |
Primary outcome
Wean off Catheter
Time frame: Post operation 3 days
% success in weaning off catheter
8 secondary outcomes
Complication rate
Time frame: Post operation 30 days
International Prostate Symptom Score (IPSS) questionnaire total Score
Time frame: Post operation 3 months & 6 months
International Prostate Symptom Score (IPSS) questionnaire QoL Score
Time frame: Post operation 3 months & 6 months
International Index of Erectile Function 5 (IIEF-5) questionnaire score
Time frame: Post operation 3 months & 6 months
Overactive bladder symptom score (OABSS) questionnaire total score
Time frame: Post operation 3 months & 6 months
Pain Score
Time frame: Post operation day 1 & 3 months
Change in urodynamic in flowrate
Time frame: Post operation 3 months
Change in urodynamic in cystometry
Time frame: Post operation 6 months
Results and safety
The study was stopped early (reason given: Equipment is not available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Benign Prostatic Hyperplasia
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong
Benign Prostatic Hyperplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquablation in people with Benign Prostatic Hyperplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Equipment is not available). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wean off Catheter (time frame: Post operation 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.