Waterjet Prostate Ablation
Primary Purpose
Benign Prostatic Hyperplasia
Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Aquablation
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
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
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aquablation
Arm Description
Surgery of benign prostatic hyperplasia by waterjet ablation
Outcomes
Primary Outcome Measures
Wean off Catheter
% success in weaning off catheter
Secondary Outcome Measures
Complication rate
Complications rate after study intervention
International Prostate Symptom Score (IPSS) questionnaire total Score
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires
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)
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)
Overactive bladder symptom score (OABSS) questionnaire total score
Change in total score in Overactive Bladder Symptom Score questionnaire (ranges from 0 - 15)
Pain Score
Post-treatment pain score ranges from 1 to 10
Change in urodynamic in flowrate
Functional outcome 1: change in urodynamic function assessed by Uroflowmetry
Change in urodynamic in cystometry
Functional outcome 2: change in urodynamic function assessed by cystometrogram (CMG)
Full Information
NCT ID
NCT03938194
First Posted
April 23, 2019
Last Updated
December 30, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03938194
Brief Title
Waterjet Prostate Ablation
Official Title
Image-guided Robot-assisted Waterjet Ablation of the Prostate for Patients With Retention of Urine Due to Benign Prostatic Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Equipment is not available
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
May 17, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aquablation
Arm Type
Experimental
Arm Description
Surgery of benign prostatic hyperplasia by waterjet ablation
Intervention Type
Procedure
Intervention Name(s)
Aquablation
Intervention Description
a novel minimally invasive water ablation therapy combining image guidance and robotics for the targeted and heat-free removal of prostate tissue
Primary Outcome Measure Information:
Title
Wean off Catheter
Description
% success in weaning off catheter
Time Frame
Post operation 3 days
Secondary Outcome Measure Information:
Title
Complication rate
Description
Complications rate after study intervention
Time Frame
Post operation 30 days
Title
International Prostate Symptom Score (IPSS) questionnaire total Score
Description
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires
Time Frame
Post operation 3 months & 6 months
Title
International Prostate Symptom Score (IPSS) questionnaire QoL Score
Description
Change in quality of life assessed by International Prostate Symptom Score questionnaire (ranges from 0 to 6)
Time Frame
Post operation 3 months & 6 months
Title
International Index of Erectile Function 5 (IIEF-5) questionnaire score
Description
Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25)
Time Frame
Post operation 3 months & 6 months
Title
Overactive bladder symptom score (OABSS) questionnaire total score
Description
Change in total score in Overactive Bladder Symptom Score questionnaire (ranges from 0 - 15)
Time Frame
Post operation 3 months & 6 months
Title
Pain Score
Description
Post-treatment pain score ranges from 1 to 10
Time Frame
Post operation day 1 & 3 months
Title
Change in urodynamic in flowrate
Description
Functional outcome 1: change in urodynamic function assessed by Uroflowmetry
Time Frame
Post operation 3 months
Title
Change in urodynamic in cystometry
Description
Functional outcome 2: change in urodynamic function assessed by cystometrogram (CMG)
Time Frame
Post operation 6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
only men have prostate
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Waterjet Prostate Ablation
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