Comparing two treatments for prostate issues
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 study is testing whether a new water vapor treatment for prostate issues works just as well as a popular lift procedure for men over 50 with BPH symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06820606 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial designed to compare the effectiveness of two treatments for benign prostatic hyperplasia (BPH): water vapor thermal treatment (REZUM) and prostatic urethral lift (UroLift). Participants will be randomly assigned to one of the two treatment arms in a 1:1 ratio. The study aims to determine if REZUM is non-inferior to UroLift in alleviating symptoms associated with BPH. The trial will focus on male patients aged 50 and older who have a specific range of prostate volume and symptom severity.
Who should consider this trial
Good fit: Ideal candidates for this study are males aged 50 and older with symptomatic BPH and an International Prostate Symptom Score (IPSS) of 13 or higher.
Not a fit: Patients with a history or high suspicion of prostate cancer or those with certain urinary tract conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with effective treatment options for managing BPH symptoms.
How similar studies have performed: Other studies have shown promising results with similar treatment approaches for BPH, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hong Kong
- Prince of Wales Hospital, The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Peter Ka-Fung CHIU
- Email: peterchiu@surgery.cuhk.edu.hk
- Phone: +852 3505 3933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.