Benign Prostatic HyperplasiaNCT06820606
Comparing Rezum and Urolift
A study testing Rezum and UroLift in people with Benign Prostatic Hyperplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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 prostatic urethral lift (UroLift) arm. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Rezum and UroLift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ≥ 50 years Symptomatic BPH International prostate symptom score (IPSS) ≥13 Prostate volume 30-80ml
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Peter Ka-Fung CHIU, 852 3505 2625, peterchiu@surgery.cuhk.edu.hk
About this study
Official title: 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Rezum, UroLift
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezumDevice
In the REZUM arm, water vapour treatment will be preformed.
UroLiftDevice
In the UroLift arm, prostatic urethral lift treatment will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Rezum | Active comparator | Not described Receives: Device: Rezum |
| UroLift | Active comparator | Not described Receives: Device: UroLift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
IPSS score ranging from 0-35 (the higher the worse)
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Secondary outcomes (11)
Hospital stays of procedure
Measure the hours of in-patient hospitalisation
Measured: From the time patient is hospitalised until the time he discharges
Number of days on Foley's catheter or self-catheterization after operation
Measured: 30 days after intervention
Complication rate
Assessed by Clavien-Dindo classification
Measured: 30 days after intervention
Post-op quality of life score (International Prostate QOL score)
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)
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Post-op quality of life score (EQ5D-5L questionnaire)
Change in quality of life assessed by Quality of life: EQ5D-5L questionnaire
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Change in voiding function in uroflowmetry (Maximum flow rate)
It is assessed by maximum flow rate (ml/s) in uroflowmetry
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Change in voiding function in uroflowmetry (Post void volume)
It is assessed by post void volume (ml) in uroflowmetry
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Post-op erectile function (IIEF-EF)
Assessed by Erectile function and Ejaculatory function using International Index of Erectile Function Questionnaire - Erectile function domain (IIEF-EF)
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Post-op erectile function (MSHQ-EjD-SF)
Assessed by Erectile function and Ejaculatory function using Male Sexual Health Questionnaire - ejaculatory dysfunction (EjD) Short Form (MSHQ-EjD-SF)
Measured: Baseline, 3 months, 6 months and 12 months after intervention
Unplanned readmission rate after operation in 30 days
Percentage of patients with unplanned readmission
Measured: 30 days after intervention
Cost of procedure and related hospitalization
Measured: At 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Alice Ho Miu Ling Nethersole Hospital, North District Hospital
- Responsible party
- Principal investigator, CHIU Ka Fung Peter, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820606
- Sponsor's protocol ID
- CRE-2024.349-T
- Status last verified
- Oct 2026
- First submitted
- 24 Jan 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ray AF, Powell J, Speakman MJ, Longford NT, DasGupta R, Bryant T, Modi S, Dyer J, Harris M, Carolan-Rees G, Hacking N. 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). BJU Int. 2018 Aug;122(2):270-282. doi: 10.1111/bju.14249. Epub 2018 May 6.
PubMed 29645352Lyauk YK, Jonker DM, Lund TM, Hooker AC, Karlsson MO. Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. AAPS J. 2020 Aug 27;22(5):115. doi: 10.1208/s12248-020-00500-w.
PubMed 32856168Elterman D, Shepherd S, Saadat SH, Alshak MN, Bhojani N, Zorn KC, Rijo E, Misrai V, Lajkosz K, Chughtai B. 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. Can J Urol. 2021 Oct;28(5):10824-10833.
PubMed 34657655Roehrborn CG, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Herron S, Rashid P, Rukstalis DB. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017 Jun;24(3):8802-8813.
PubMed 28646935McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. 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. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.
PubMed 26614889McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. 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. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19.
PubMed 33872051Teo JS, Lee YM, Ho HSS. An update on transurethral surgery for benign prostatic obstruction. Asian J Urol. 2017 Jul;4(3):195-198. doi: 10.1016/j.ajur.2017.06.006. Epub 2017 Jun 15.
PubMed 29264231Yip SK, Chan NH, Chiu P, Lee KW, Ng CF. A randomized controlled trial comparing the efficacy of hybrid bipolar transurethral vaporization and resection of the prostate with bipolar transurethral resection of the prostate. J Endourol. 2011 Dec;25(12):1889-94. doi: 10.1089/end.2011.0269. Epub 2011 Sep 16.
PubMed 21923418Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3.
PubMed 26042336Yee CH, Wong JH, Chiu PK, Teoh JY, Chan CK, Chan ES, Hou SM, Ng CF. Secondary hemorrhage after bipolar transurethral resection and vaporization of prostate. Urol Ann. 2016 Oct-Dec;8(4):458-463. doi: 10.4103/0974-7796.192110.
PubMed 28057992Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available.
PubMed 29938669Madersbacher S, Lackner J, Brossner C, Rohlich M, Stancik I, Willinger M, Schatzl G; Prostate Study Group of the Austrian Society of Urology. Reoperation, myocardial infarction and mortality after transurethral and open prostatectomy: a nation-wide, long-term analysis of 23,123 cases. Eur Urol. 2005 Apr;47(4):499-504. doi: 10.1016/j.eururo.2004.12.010. Epub 2005 Jan 23.
PubMed 15774249Zhang W, Zhang X, Li H, Wu F, Wang H, Zhao M, Hu H, Xu K. Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study. BMJ Open. 2019 Jun 19;9(6):e022792. doi: 10.1136/bmjopen-2018-022792.
PubMed 31221864
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06820606
- Acronym / sponsor ID
- CRE-2024.349-T
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Alice Ho Miu Ling Nethersole Hospital, North District Hospital
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rezum | Active comparator | Device: Rezum |
| UroLift | Active comparator | Device: UroLift |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male ≥ 50 years Symptomatic BPH International prostate symptom score (IPSS) ≥13 Prostate volume 30-80ml
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RezumIn the REZUM arm, water vapour treatment will be preformed. | Device | Rezum |
| UroLiftIn the UroLift arm, prostatic urethral lift treatment will be performed. | Device | UroLift |
Primary outcome
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)
11 secondary outcomes
Hospital stays of procedure
Time frame: 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
Complication rate
Time frame: 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
Post-op quality of life score (EQ5D-5L questionnaire)
Time frame: 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
Change in voiding function in uroflowmetry (Post void volume)
Time frame: 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
Post-op erectile function (MSHQ-EjD-SF)
Time frame: Baseline, 3 months, 6 months and 12 months after intervention
Unplanned readmission rate after operation in 30 days
Time frame: 30 days after intervention
Cost of procedure and related hospitalization
Time frame: At 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 29645352Ray AF, Powell J, Speakman MJ, Longford NT, DasGupta R, Bryant T, Modi S, Dyer J, Harris M, Carolan-Rees G, Hacking N. 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). BJU Int. 2018 Aug;122(2):270-282. doi: 10.1111/bju.14249. Epub 2018 May 6.
- Background: PubMed 32856168Lyauk YK, Jonker DM, Lund TM, Hooker AC, Karlsson MO. Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. AAPS J. 2020 Aug 27;22(5):115. doi: 10.1208/s12248-020-00500-w.
- Background: PubMed 34657655Elterman D, Shepherd S, Saadat SH, Alshak MN, Bhojani N, Zorn KC, Rijo E, Misrai V, Lajkosz K, Chughtai B. 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. Can J Urol. 2021 Oct;28(5):10824-10833.
- Background: PubMed 28646935Roehrborn CG, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Herron S, Rashid P, Rukstalis DB. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017 Jun;24(3):8802-8813.
- Background: PubMed 26614889McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. 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. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.
- Background: PubMed 33872051McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. 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. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19.
- Background: PubMed 29264231Teo JS, Lee YM, Ho HSS. An update on transurethral surgery for benign prostatic obstruction. Asian J Urol. 2017 Jul;4(3):195-198. doi: 10.1016/j.ajur.2017.06.006. Epub 2017 Jun 15.
- Background: PubMed 21923418Yip SK, Chan NH, Chiu P, Lee KW, Ng CF. A randomized controlled trial comparing the efficacy of hybrid bipolar transurethral vaporization and resection of the prostate with bipolar transurethral resection of the prostate. J Endourol. 2011 Dec;25(12):1889-94. doi: 10.1089/end.2011.0269. Epub 2011 Sep 16.
- Background: PubMed 26042336Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3.
- Background: PubMed 28057992Yee CH, Wong JH, Chiu PK, Teoh JY, Chan CK, Chan ES, Hou SM, Ng CF. Secondary hemorrhage after bipolar transurethral resection and vaporization of prostate. Urol Ann. 2016 Oct-Dec;8(4):458-463. doi: 10.4103/0974-7796.192110.
- Background: PubMed 29938669Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available.
- Background: PubMed 15774249Madersbacher S, Lackner J, Brossner C, Rohlich M, Stancik I, Willinger M, Schatzl G; Prostate Study Group of the Austrian Society of Urology. Reoperation, myocardial infarction and mortality after transurethral and open prostatectomy: a nation-wide, long-term analysis of 23,123 cases. Eur Urol. 2005 Apr;47(4):499-504. doi: 10.1016/j.eururo.2004.12.010. Epub 2005 Jan 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rezum and UroLift in people with Benign Prostatic Hyperplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Ka-Fung CHIU (+852 3505 2625, peterchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment (time frame: Baseline, 3 months, 6 months and 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06820606, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.