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Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05762198
Collaborator
(none)
108
Enrollment
1
Location
2
Arms
38
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Rezūm
  • Device: TURP
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP in Men With Benign Prostatic Hyperplasia in Refractory Urinary Retention
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2026
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rezūm

Device: Rezūm
In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.
Active Comparator: TURP

Device: TURP
In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia

Outcome Measures

Primary Outcome Measures

  1. Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment [Baseline, 3 months, 6 months and 12 months after intervention]

    IPSS score ranging from 0-35 (the higher the worse)

Secondary Outcome Measures

  1. Successful trial without catheter (TWOC) within 3 months [At 3 months]

    Percentage of patients successfully TWOC

  2. Complication rate [30 days after intervention]

    Assessed by Clavien-Dindo classification

  3. Post-op quality of life score [Baseline, 3 months, 6 months and 12 months after intervention]

    Change in quality of life assessed by change in International Prostate QOL score (ranges from 0 to 6, the higher the worse)

  4. Change in voiding function in uroflowmetry [Baseline, 3 months, 6 months and 12 months after intervention]

    It is assessed by maximum flow rate and post void volume in uroflowmetry

  5. Post-op International Index of Erectile function score [Baseline, 3 months, 6 months and 12 months after intervention]

    Score 1-5 (the lower the worse)

  6. Hospital stays of procedure [On Discharge]

    Measure the hours of in-patient hospitalisation

  7. Unplanned readmission rate after operation in 30 days [30 days after intervention]

    Percentage of patients with unplanned readmission

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prince of Wales Hospital, Chinese University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Peter Ka-Fung CHIU, FRCS, PhD, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
CHIU Ka Fung Peter, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05762198
Other Study ID Numbers:
  • CRE-2022.537-T
First Posted:
Mar 9, 2023
Last Update Posted:
Mar 16, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Mar 16, 2023