NCT03938194

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2021

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

2.1 years

First QC Date

April 23, 2019

Last Update Submit

December 30, 2021

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Wean off Catheter

    % success in weaning off catheter

    Post operation 3 days

Secondary Outcomes (8)

  • Complication rate

    Post operation 30 days

  • International Prostate Symptom Score (IPSS) questionnaire total Score

    Post operation 3 months & 6 months

  • International Prostate Symptom Score (IPSS) questionnaire QoL Score

    Post operation 3 months & 6 months

  • International Index of Erectile Function 5 (IIEF-5) questionnaire score

    Post operation 3 months & 6 months

  • Overactive bladder symptom score (OABSS) questionnaire total score

    Post operation 3 months & 6 months

  • +3 more secondary outcomes

Study Arms (1)

Aquablation

EXPERIMENTAL

Surgery of benign prostatic hyperplasia by waterjet ablation

Procedure: Aquablation

Interventions

AquablationPROCEDURE

a novel minimally invasive water ablation therapy combining image guidance and robotics for the targeted and heat-free removal of prostate tissue

Aquablation

Eligibility Criteria

Age50 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsonly men have prostate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Retention of urine refractory to medical treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Aquablation

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Associate Professor

Study Record Dates

First Submitted

April 23, 2019

First Posted

May 6, 2019

Study Start

April 25, 2019

Primary Completion

May 17, 2021

Study Completion

October 21, 2021

Last Updated

January 14, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)