STEAM-MAP 1 Study - Steam Therapy With MRI and AI-assisted Planning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI-TRUS fusion-guided Rezūm therapy.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia (BPH). Basic parameters: 30 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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. .
Interventions
- 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.
Primary outcome measures
- Feasibility: Success rate defined by completion of cases [Time frame: Peri-operative period]
Secondary outcome measures (11)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 3 centers
- Prince of Wales Hospital — Shatin
- North District Hospital — Sheung Shui
- Alice Ho Miu Ling Nethersole Hospital — Tai Po
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. PMID 33415211
- 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. PMID 29527813
Identifiers
NCT: NCT07663344 · CRE-2026.116