Comparing Rezum and Urolift

February 12, 2025 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

A Randomized Controlled Trial Comparing Efficacy and Cost Effectiveness of Water Vapour Thermal Therapy (Rezum) and Prostatic Urethral Lift (UroLift) in Men With Benign Prostatic Hyperplasia

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 prostatic urethral lift (UroLift) arm.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital, The Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male ≥ 50 years Symptomatic BPH International prostate symptom score (IPSS) ≥13 Prostate volume 30-80ml

Exclusion Criteria:

  • History or high suspicion of prostate cancer
  • Current urinary tract infection
  • Refractory urinary retention or post-void residual (PVR) ≥250 mL
  • Intravesical prostatic protrusion (IPP)>10mm
  • Prior prostate surgery
  • Known or suspected allergy to nickel, titanium, or polyester/polypropylene
  • Urethral stricture, meatal stenosis, bladder neck contracture
  • Neurogenic bladder and/or sphincter abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rezum
Device: Rezum
In the REZUM arm, water vapour treatment will be preformed.
Active Comparator: UroLift
Device: UroLift
In the UroLift arm, prostatic urethral lift treatment will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
Time Frame: Baseline, 3 months, 6 months and 12 months after intervention
IPSS score ranging from 0-35 (the higher the worse)
Baseline, 3 months, 6 months and 12 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 30 days after intervention
Assessed by Clavien-Dindo classification
30 days after intervention
Unplanned readmission rate after operation in 30 days
Time Frame: 30 days after intervention
Percentage of patients with unplanned readmission
30 days after intervention
Hospital stays of procedure
Time Frame: From the time patient is hospitalised until the time he discharges
Measure the hours of in-patient hospitalisation
From the time patient is hospitalised until the time he discharges
Number of days on Foley's catheter or self-catheterization after operation
Time Frame: 30 days after intervention
30 days after intervention
Post-op quality of life score (International Prostate QOL score)
Time Frame: 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; 0 being the best while 6 being the worst)
Baseline, 3 months, 6 months and 12 months after intervention
Post-op quality of life score (EQ5D-5L questionnaire)
Time Frame: Baseline, 3 months, 6 months and 12 months after intervention
Change in quality of life assessed by Quality of life: EQ5D-5L questionnaire
Baseline, 3 months, 6 months and 12 months after intervention
Change in voiding function in uroflowmetry (Maximum flow rate)
Time Frame: Baseline, 3 months, 6 months and 12 months after intervention
It is assessed by maximum flow rate (ml/s) in uroflowmetry
Baseline, 3 months, 6 months and 12 months after intervention
Change in voiding function in uroflowmetry (Post void volume)
Time Frame: Baseline, 3 months, 6 months and 12 months after intervention
It is assessed by post void volume (ml) in uroflowmetry
Baseline, 3 months, 6 months and 12 months after intervention
Post-op erectile function (IIEF-EF)
Time Frame: Baseline, 3 months, 6 months and 12 months after intervention
Assessed by Erectile function and Ejaculatory function using International Index of Erectile Function Questionnaire - Erectile function domain (IIEF-EF)
Baseline, 3 months, 6 months and 12 months after intervention
Post-op erectile function (MSHQ-EjD-SF)
Time Frame: Baseline, 3 months, 6 months and 12 months after intervention
Assessed by Erectile function and Ejaculatory function using Male Sexual Health Questionnaire - ejaculatory dysfunction (EjD) Short Form (MSHQ-EjD-SF)
Baseline, 3 months, 6 months and 12 months after intervention
Cost of procedure and related hospitalization
Time Frame: At 12 months after treatment
At 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2024.349-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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