Actively Recruiting

Phase Not Applicable
Age: 50Years +
MALE
ID06820606

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

Led by Chinese University of Hong Kong · Updated on 2025-02-14

120

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial is a randomized controlled study comparing two treatments for men with symptomatic benign prostatic hyperplasia (BPH), a condition affecting the prostate. The study uses a non-inferiority design to see if the water vapour thermal treatment (REZUM) is not worse than the prostatic urethral lift (UroLift) in relieving symptoms. The trial is sponsored by the Chinese University of Hong Kong and focuses on males aged 50 and older with specific prostate characteristics and symptom scores. Participants are randomly assigned to one of two groups: the REZUM group receiving water vapour therapy or the UroLift group undergoing prostatic urethral lift treatment. Both treatments are device-based procedures aimed at improving urinary symptoms caused by an enlarged prostate. The study monitors changes in symptoms over 12 months, with evaluations at baseline, 3, 6, and 12 months. During the study, participants will undergo assessments including the International Prostate Symptom Score (IPSS), quality of life questionnaires, uroflowmetry tests measuring urine flow and residual volume, and evaluations of erectile function. Hospital stay length, catheter use, complication rates, readmission rates, and costs related to the procedures will also be recorded. Follow-up visits occur up to 12 months after treatment to track these outcomes and safety.

CONDITIONS

Brief Title

Comparing Rezum and Urolift

Who Can Participate

Age: 50Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 50 years or older
  • Symptomatic benign prostatic hyperplasia (BPH)
  • International Prostate Symptom Score (IPSS) of 13 or higher
  • Prostate volume between 30 and 80 milliliters
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants receive either water vapour thermal therapy (Rezum) or prostatic urethral lift (UroLift) treatment for benign prostatic hyperplasia.

1 procedure visit (in-person)

Post-operative Follow-up

Duration - 12 months

Participants are monitored for recovery and assessed for symptom changes and quality of life after the treatment.

Visits at baseline, 3 months, 6 months, and 12 months after intervention

Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

P

Peter Ka-Fung CHIU

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study).

Alistair F Ray, John Powell, Mark J Speakman...

https://pubmed.ncbi.nlm.nih.gov/29645352

Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

Yassine Kamal Lyauk, Daniël M Jonker, Trine Meldgaard Lund...

https://pubmed.ncbi.nlm.nih.gov/32856168

Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes.

Dean Elterman, Shaun Shepherd, Seyed Hossein Saadat...

https://pubmed.ncbi.nlm.nih.gov/34657655

Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Kevin T McVary, Steven N Gange, Marc C Gittelman...

https://pubmed.ncbi.nlm.nih.gov/26614889

Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Kevin T McVary, Marc C Gittelman, Kenneth A Goldberg...

https://pubmed.ncbi.nlm.nih.gov/33872051

A randomized controlled trial comparing the efficacy of hybrid bipolar transurethral vaporization and resection of the prostate with bipolar transurethral resection of the prostate.

Sidney K Yip, Ning Hong Chan, Peter Chiu...

https://pubmed.ncbi.nlm.nih.gov/21923418

Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection.

Chi-hang Yee, Joseph Hon-ming Wong, Peter Ka-fung Chiu...

https://pubmed.ncbi.nlm.nih.gov/26042336