Back to resultsComparing Water Vapour Thermal Therapy (Rezūm) and TURP
Primary Purpose
Prostate Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Rezūm
TURP
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Men 50-80 years Refractory urinary retention related to benign prostatic hyperplasia (BPH) On urethral Foley's catheter before treatment Prostate size 30-80ml on ultrasound Exclusion Criteria: Prior prostate operation Past or current history of prostate cancer Strong suspicion of prostate cancer (e.g. Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer) Known Urethral stricture / Bladder stone / Hypocontractile bladder Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke) Contraindicated to undergo TURP or REZUM (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
Sites / Locations
- Prince of Wales Hospital, Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rezūm
TURP
Arm Description
Outcomes
Primary Outcome Measures
Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
IPSS score ranging from 0-35 (the higher the worse)
Secondary Outcome Measures
Successful trial without catheter (TWOC) within 3 months
Percentage of patients successfully TWOC
Complication rate
Assessed by Clavien-Dindo classification
Post-op quality of life score
Change in quality of life assessed by change in International Prostate QOL score (ranges from 0 to 6, the higher the worse)
Change in voiding function in uroflowmetry
It is assessed by maximum flow rate and post void volume in uroflowmetry
Post-op International Index of Erectile function score
Score 1-5 (the lower the worse)
Hospital stays of procedure
Measure the hours of in-patient hospitalisation
Unplanned readmission rate after operation in 30 days
Percentage of patients with unplanned readmission
Full Information
NCT ID
NCT05762198
First Posted
February 28, 2023
Last Updated
March 14, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05762198
Brief Title
Comparing Water Vapour Thermal Therapy (Rezūm) and TURP
Official Title
A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP in Men With Benign Prostatic Hyperplasia in Refractory Urinary Retention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
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
This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or transurethral resection of prostate (TURP) arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rezūm
Arm Type
Active Comparator
Arm Title
TURP
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Rezūm
Intervention Description
In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.
Intervention Type
Device
Intervention Name(s)
TURP
Intervention Description
In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia
Primary Outcome Measure Information:
Title
Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
Description
IPSS score ranging from 0-35 (the higher the worse)
Time Frame
Baseline, 3 months, 6 months and 12 months after intervention
Secondary Outcome Measure Information:
Title
Successful trial without catheter (TWOC) within 3 months
Description
Percentage of patients successfully TWOC
Time Frame
At 3 months
Title
Complication rate
Description
Assessed by Clavien-Dindo classification
Time Frame
30 days after intervention
Title
Post-op quality of life score
Description
Change in quality of life assessed by change in International Prostate QOL score (ranges from 0 to 6, the higher the worse)
Time Frame
Baseline, 3 months, 6 months and 12 months after intervention
Title
Change in voiding function in uroflowmetry
Description
It is assessed by maximum flow rate and post void volume in uroflowmetry
Time Frame
Baseline, 3 months, 6 months and 12 months after intervention
Title
Post-op International Index of Erectile function score
Description
Score 1-5 (the lower the worse)
Time Frame
Baseline, 3 months, 6 months and 12 months after intervention
Title
Hospital stays of procedure
Description
Measure the hours of in-patient hospitalisation
Time Frame
On Discharge
Title
Unplanned readmission rate after operation in 30 days
Description
Percentage of patients with unplanned readmission
Time Frame
30 days after intervention
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men 50-80 years
Refractory urinary retention related to benign prostatic hyperplasia (BPH)
On urethral Foley's catheter before treatment
Prostate size 30-80ml on ultrasound
Exclusion Criteria:
Prior prostate operation
Past or current history of prostate cancer
Strong suspicion of prostate cancer (e.g. Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer)
Known Urethral stricture / Bladder stone / Hypocontractile bladder
Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke)
Contraindicated to undergo TURP or REZUM (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Ka-Fung CHIU, FRCS, PhD
Phone
35051663
Email
peterchiu@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ka-Fung CHIU, FRCS, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital, Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29938669
Citation
Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available.
Results Reference
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Citation
Yee CH, Wong JH, Chiu PK, Teoh JY, Chan CK, Chan ES, Hou SM, Ng CF. Secondary hemorrhage after bipolar transurethral resection and vaporization of prostate. Urol Ann. 2016 Oct-Dec;8(4):458-463. doi: 10.4103/0974-7796.192110.
Results Reference
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PubMed Identifier
26042336
Citation
Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Comparing Water Vapour Thermal Therapy (Rezūm) and TURP
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