STEAM-MAP 1 Study - Steam Therapy With MRI and AI-assisted Planning

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Procedure: MRI-TRUS fusion-guided Rezūm therapy

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qinyang Alex Liu, MBBS, MSc, FRCSEd; Phone Number: 852+35052625; Email: alexliu@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Hong Tim Lau, MSc; Phone Number: 852+35053933; Email: timlau@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong, 999077
    • Prince of Wales Hospital
    • Contact: Alex Qinyang LIU, MBBS, MSc, FRCSEd; Phone Number: 852+35052625; Email: alexliu@surgery.cuhk.edu.hk
    • Contact: Chi Fai NG, MBChB, MD, FRCSEd; Phone Number: 852+35052625; Email: ngcf@surgery.cuhk.edu.hk
    • Principal Investigator: Alex Qinyang LIU, MBBS, MSc, FRCSEd
    • Sub-Investigator: Chi Fai NG, MD, FRCS Ed, FHKAM, MBChB
    • Sub-Investigator: Yuen Chun Jeremy TEOH, MD, FRCS Ed, FCSHK, FHKAM
    • Sub-Investigator: Ka Fung Peter CHIU, PhD, FRCSEd, FHKAM, MBChB
  • Sheung Shui, Hong Kong
    • North District Hospital
    • Contact: Kar Kei Steffi YUEN, MBBS, FRCS Ed, FHKAM, FCSHK; Phone Number: 35052625; Email: steffiyuen@surgery.cuhk.edu.hk
    • Sub-Investigator: Kar Kei Steffi YUEN, MBBS, FRCS Ed, FHKAM, FCSHK
  • Tai Po, Hong Kong
    • Alice Ho Miu Ling Nethersole Hospital
    • Contact: Ka Lun LO, FRCS Ed, FHKAM, FHKCS, MBChB; Phone Number: 35052625; Email: lokalun@surgery.cuhk.edu.hk
    • Sub-Investigator: Ka Lun LO, MBChB, FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI-TRUS fusion water vapour ablation; The intervenitons will consist of MRI segmentation and image-informed injection planning, with documentation of planned and delivered injection sites and performance metrics.	Procedure: MRI-TRUS fusion-guided Rezūm therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility: Success rate defined by completion of cases	Peri-operative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of operation	The time between scope in and scope out	Intra-operation
Duration of Software fusion time		Intra-operation
Number of treatment given during the operation		Intra-operation
Rate of discharge on the same day of the operation		On the day 1 of operation
Duration of hospital stay	Duration of hospital stay in hour since completion of operation	Peri-operative period
Duration of catheter time in hour since completion of operation		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.	Month 1
Hospital readmission rate since completion of the operation		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	Baseline and Month 3
Change in voiding function in uroflowmetry	It is assessed by maximum flow rate and post void volume in uroflowmetry	Baseline and Month 3
Prostate size	Assessed by transrectal ultrasound	Baseline and Month 3

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Publications and helpful links

General 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.
• Liao 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Water vapor thermal therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: CRE-2026.116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No