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出境医 / 临床实验 / Waterjet Prostate Ablation

Waterjet Prostate Ablation

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.


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Procedure: Aquablation Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image-guided Robot-assisted Waterjet Ablation of the Prostate for Patients With Retention of Urine Due to Benign Prostatic Obstruction
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
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

Outcome Measures
Primary Outcome Measures :
  1. Wean off Catheter [ Time Frame: Post operation 3 days ]
    % success in weaning off catheter


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: Post operation 30 days ]
    Complications rate after study intervention

  2. International Prostate Symptom Score (IPSS) questionnaire total Score [ Time Frame: Post operation 3 months & 6 months ]
    Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires

  3. International Prostate Symptom Score (IPSS) questionnaire QoL Score [ Time Frame: Post operation 3 months & 6 months ]
    Change in quality of life assessed by International Prostate Symptom Score questionnaire (ranges from 0 to 6)

  4. International Index of Erectile Function 5 (IIEF-5) questionnaire score [ Time Frame: Post operation 3 months & 6 months ]
    Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25)

  5. Overactive bladder symptom score (OABSS) questionnaire total score [ Time Frame: Post operation 3 months & 6 months ]
    Change in total score in Overactive Bladder Symptom Score questionnaire (ranges from 0 - 15)

  6. Pain Score [ Time Frame: Post operation day 1 & 3 months ]
    Post-treatment pain score ranges from 1 to 10

  7. Change in urodynamic in flowrate [ Time Frame: Post operation 3 months ]
    Functional outcome 1: change in urodynamic function assessed by Uroflowmetry

  8. Change in urodynamic in cystometry [ Time Frame: Post operation 6 months ]
    Functional outcome 2: change in urodynamic function assessed by cystometrogram (CMG)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only men have prostate
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Chi Hang Yee, MBBS 35051663 yeechihang@surgery.cuhk.edu.hk
Contact: Siu Ying Yip, MPH 35051663 siuying@surgery.cuhk.edu.hk

Locations
Layout table for location information
Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: SIU YING YIP, MPH       siuying@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE April 25, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
Wean off Catheter [ Time Frame: Post operation 3 days ]
% success in weaning off catheter
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Complication rate [ Time Frame: Post operation 30 days ]
    Complications rate after study intervention
  • International Prostate Symptom Score (IPSS) questionnaire total Score [ Time Frame: Post operation 3 months & 6 months ]
    Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires
  • International Prostate Symptom Score (IPSS) questionnaire QoL Score [ Time Frame: Post operation 3 months & 6 months ]
    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 [ Time Frame: Post operation 3 months & 6 months ]
    Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25)
  • Overactive bladder symptom score (OABSS) questionnaire total score [ Time Frame: Post operation 3 months & 6 months ]
    Change in total score in Overactive Bladder Symptom Score questionnaire (ranges from 0 - 15)
  • Pain Score [ Time Frame: Post operation day 1 & 3 months ]
    Post-treatment pain score ranges from 1 to 10
  • Change in urodynamic in flowrate [ Time Frame: Post operation 3 months ]
    Functional outcome 1: change in urodynamic function assessed by Uroflowmetry
  • Change in urodynamic in cystometry [ Time Frame: Post operation 6 months ]
    Functional outcome 2: change in urodynamic function assessed by cystometrogram (CMG)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Waterjet Prostate Ablation
Official Title  ICMJE Image-guided Robot-assisted Waterjet Ablation of the Prostate for Patients With Retention of Urine Due to Benign Prostatic Obstruction
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE Procedure: Aquablation
a novel minimally invasive water ablation therapy combining image guidance and robotics for the targeted and heat-free removal of prostate tissue
Study Arms  ICMJE Experimental: Aquablation
Surgery of benign prostatic hyperplasia by waterjet ablation
Intervention: Procedure: Aquablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: only men have prostate
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chi Hang Yee, MBBS 35051663 yeechihang@surgery.cuhk.edu.hk
Contact: Siu Ying Yip, MPH 35051663 siuying@surgery.cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03938194
Other Study ID Numbers  ICMJE CRE 2019.043
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chi Hang Yee, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese University of Hong Kong
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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