Comparing two treatments for urinary retention in men with prostate issues
A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP in Men With Benign Prostatic Hyperplasia in Refractory Urinary Retention
This study is testing whether a new treatment using water vapor can help men aged 50-80 with prostate issues and urinary retention just as well as the standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05762198 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial designed to compare the effectiveness of water vapour thermal therapy (Rezūm) against transurethral resection of the prostate (TURP) in treating men aged 50-80 who experience urinary retention due to benign prostatic hyperplasia (BPH). Participants will be randomly assigned to one of the two treatment arms in a 1:1 ratio. The study aims to determine if Rezūm is as effective as TURP in alleviating urinary retention symptoms. The trial will include men who are currently on a urethral Foley's catheter and have specific prostate size criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 50-80 with refractory urinary retention related to BPH who are currently using a urethral Foley's catheter.
Not a fit: Patients with a history of prostate cancer or those with conditions that contraindicate TURP or Rezūm will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for men suffering from urinary retention due to BPH.
How similar studies have performed: Other studies have shown promising results with Rezūm therapy, indicating that this approach may be effective, although direct comparisons with TURP are less common.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hong Kong
- Prince of Wales Hospital, Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Peter Ka-Fung CHIU, FRCS, PhD — Chinese University of Hong Kong
- Study coordinator: Peter Ka-Fung CHIU, FRCS, PhD
- Email: peterchiu@surgery.cuhk.edu.hk
- Phone: 35051663
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.