Benign Prostatic Hyperplasia (BPH)NCT07663344
STEAM-MAP 1 Study - Steam Therapy With MRI and AI-assisted Planning
A study testing MRI-TRUS fusion-guided Rezūm therapy in people with Benign Prostatic Hyperplasia (BPH), run by Chinese University of Hong Kong at 3 sites in Hong Kong.
Trial summary
The STEAM-MAP 1 Study is a single-arm, prospective feasibility trial evaluating the integration of MRI-transrectal ultrasound (TRUS) fusion guidance into Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- MRI-TRUS fusion-guided Rezūm therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesHong Kong
- Study dates
- 1 Jun 2026to 31 Mar 2028
- 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 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-80 years old with symptomatic BPH.
- Prostate volume 30-80 mL (TRUS/MRI/US)
- Suitable for Rezum.
- Able to consent and comply with follow-up to 1 month.
- With prior prostate MRI within 2 years
Who cannot join
- Known/suspected prostate cancer requiring oncologic management.
- Prior prostate surgery impacting urethral anatomy within 12 months.
- Prior implant affecting urethral anatomy.
- Active UTI or untreated bacteriuria pre-op.
- Uncorrectable coagulopathy; inability to manage antithrombotics.
- Severe medical comorbidity precluding endoscopy.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong3 sites
Prince of Wales Hospital
Shatin, 999077
Alex Qinyang LIU, MBBS, MSc, FRCSEd, 852+35052625, alexliu@surgery.cuhk.edu.hk
Chi Fai NG, MBChB, MD, FRCSEd, 852+35052625, ngcf@surgery.cuhk.edu.hk
North District Hospital
Sheung Shui
Kar Kei Steffi YUEN, MBBS, FRCS Ed, FHKAM, FCSHK, 35052625, steffiyuen@surgery.cuhk.edu.hk
Kar Kei Steffi YUEN, MBBS, FRCS Ed, FHKAM, FCSHK
Alice Ho Miu Ling Nethersole Hospital
Tai Po
Ka Lun LO, FRCS Ed, FHKAM, FHKCS, MBChB, 35052625, lokalun@surgery.cuhk.edu.hk
Ka Lun LO, MBChB, FRCS
About this study
Official title: Prospective Feasibility Trial on MRI-TRUS Fusion Water Vapour Ablation for Benign Prostatic Hyperplasia (STEAM-MAP 1 Study - Steam Therapy With MRI and AI-assisted Planning)
The STEAM-MAP 1 Study is a single-arm, prospective feasibility trial evaluating the integration of MRI-transrectal ultrasound (TRUS) fusion guidance into Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH).
Read the detailed description
This study aims to assess the feasibility, procedural characteristics, and early safety of MRI-TRUS fusion-guided planning and delivery of Rezūm water vapor therapy in men with symptomatic benign prostatic hyperplasia.
Eligible patients with prior MRI prostate fulfilling the eligibility criteria will be enrolled from the participating hospitals. Baseline assessment including symptom severity and uroflowmetric measurements, urine culture will be performed in the usual routine pre-Rezūm nurse-led clinics. The intervention will consist of MRI segmentation and image-informed injection planning, with documentation of planned and delivered injection sites and performance metrics. .
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- MRI-TRUS fusion-guided Rezūm therapy
- Keywords
- Water vapor thermal therapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-TRUS fusion-guided Rezūm therapyProcedure or surgery
This study involves MRI-TRUS fusion-guided planning and delivery of Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH). All participants will receive the investigational workflow during their Rezūm procedure. This is a single-arm study with no concurrent control group.
| Study group | Role | What they receive |
|---|---|---|
| MRI-TRUS fusion water vapour ablation | Experimental | The intervenitons will consist of MRI segmentation and image-informed injection planning, with documentation of planned and delivered injection sites and performance metrics. Receives: Procedure: MRI-TRUS fusion-guided Rezūm therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Success rate defined by completion of cases
Measured: Peri-operative period
Secondary outcomes (11)
Duration of operation
The time between scope in and scope out
Measured: Intra-operation
Duration of Software fusion time
Measured: Intra-operation
Number of treatment given during the operation
Measured: Intra-operation
Rate of discharge on the same day of the operation
Measured: On the day 1 of operation
Duration of hospital stay
Duration of hospital stay in hour since completion of operation
Measured: Peri-operative period
Duration of catheter time in hour since completion of operation
Measured: Peri-operative period
Adverse events (AE) and serious adverse events (SAE) related to the treatment
The severity of AE is grade by Clavien-Dindo classification.
Measured: Month 1
Hospital readmission rate since completion of the operation
Measured: Month 1
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom
Measured: Baseline and Month 3
Change in voiding function in uroflowmetry
It is assessed by maximum flow rate and post void volume in uroflowmetry
Measured: Baseline and Month 3
Prostate size
Assessed by transrectal ultrasound
Measured: Baseline and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Qinyang Liu, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663344
- Sponsor's protocol ID
- CRE-2026.116
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang AY, Xu X. Prevalence, Burden, and Treatment of Lower Urinary Tract Symptoms in Men Aged 50 and Older: A Systematic Review of the Literature. SAGE Open Nurs. 2018 Dec 26;4:2377960818811773. doi: 10.1177/2377960818811773. eCollection 2018 Jan-Dec.
PubMed 33415211Liao L, Chuang YC, Liu SP, Lee KS, Yoo TK, Chu R, Sumarsono B, Wang JY. Effect of lower urinary tract symptoms on the quality of life and sexual function of males in China, Taiwan, and South Korea: Subgroup analysis of a cross-sectional, population-based study. Low Urin Tract Symptoms. 2019 Apr;11(2):O78-O84. doi: 10.1111/luts.12220. Epub 2018 Mar 11.
PubMed 29527813
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Feasibility Trial on MRI-TRUS Fusion Water Vapour Ablation for Benign Prostatic Hyperplasia (STEAM-MAP 1 Study - Steam Therapy With MRI and AI-assisted Planning)
- ClinicalTrials.gov ID
- NCT07663344
- Acronym / sponsor ID
- CRE-2026.116
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Water vapor thermal therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 23 Jun 2026 (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.
The STEAM-MAP 1 Study is a single-arm, prospective feasibility trial evaluating the integration of MRI-transrectal ultrasound (TRUS) fusion guidance into Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH).
Detailed description
This study aims to assess the feasibility, procedural characteristics, and early safety of MRI-TRUS fusion-guided planning and delivery of Rezūm water vapor therapy in men with symptomatic benign prostatic hyperplasia.
Eligible patients with prior MRI prostate fulfilling the eligibility criteria will be enrolled from the participating hospitals. Baseline assessment including symptom severity and uroflowmetric measurements, urine culture will be performed in the usual routine pre-Rezūm nurse-led clinics. The intervention will consist of MRI segmentation and image-informed injection planning, with documentation of planned and delivered injection sites and performance metrics. .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-TRUS fusion water vapour ablation | Experimental | Procedure: MRI-TRUS fusion-guided Rezūm therapyThe intervenitons will consist of MRI segmentation and image-informed injection planning, with documentation of planned and delivered injection sites and performance metrics. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30-80 years old with symptomatic BPH.
- Prostate volume 30-80 mL (TRUS/MRI/US)
- Suitable for Rezum.
- Able to consent and comply with follow-up to 1 month.
- With prior prostate MRI within 2 years
Key exclusion criteria (6 listed)
- Known/suspected prostate cancer requiring oncologic management.
- Prior prostate surgery impacting urethral anatomy within 12 months.
- Prior implant affecting urethral anatomy.
- Active UTI or untreated bacteriuria pre-op.
- Uncorrectable coagulopathy; inability to manage antithrombotics.
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 |
|---|---|---|
| MRI-TRUS fusion-guided Rezūm therapyThis study involves MRI-TRUS fusion-guided planning and delivery of Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH). All participants will receive the investigational workflow during their Rezūm procedure. This is a single-arm study with no concurrent control group. | Procedure or surgery | MRI-TRUS fusion water vapour ablation |
Primary outcome
Feasibility: Success rate defined by completion of cases
Time frame: Peri-operative period
11 secondary outcomes
Duration of operation
Time frame: Intra-operation
Duration of Software fusion time
Time frame: Intra-operation
Number of treatment given during the operation
Time frame: Intra-operation
Rate of discharge on the same day of the operation
Time frame: On the day 1 of operation
Duration of hospital stay
Time frame: Peri-operative period
Duration of catheter time in hour since completion of operation
Time frame: Peri-operative period
Adverse events (AE) and serious adverse events (SAE) related to the treatment
Time frame: Month 1
Hospital readmission rate since completion of the operation
Time frame: Month 1
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
Time frame: Baseline and Month 3
Change in voiding function in uroflowmetry
Time frame: Baseline and Month 3
Prostate size
Time frame: Baseline and Month 3
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 23 Jun 2026.
- Background: PubMed 33415211Zhang AY, Xu X. Prevalence, Burden, and Treatment of Lower Urinary Tract Symptoms in Men Aged 50 and Older: A Systematic Review of the Literature. SAGE Open Nurs. 2018 Dec 26;4:2377960818811773. doi: 10.1177/2377960818811773. eCollection 2018 Jan-Dec.
- Background: PubMed 29527813Liao L, Chuang YC, Liu SP, Lee KS, Yoo TK, Chu R, Sumarsono B, Wang JY. Effect of lower urinary tract symptoms on the quality of life and sexual function of males in China, Taiwan, and South Korea: Subgroup analysis of a cross-sectional, population-based study. Low Urin Tract Symptoms. 2019 Apr;11(2):O78-O84. doi: 10.1111/luts.12220. Epub 2018 Mar 11.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-TRUS fusion-guided Rezūm therapy in people with Benign Prostatic Hyperplasia (BPH), run by Chinese University of Hong Kong at 3 sites 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Qinyang Alex Liu, MBBS, MSc, FRCSEd (852+35052625, alexliu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Success rate defined by completion of cases (time frame: Peri-operative period). 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 NCT07663344, which also lists 2 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 23 Jun 2026.