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

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. .

• MRI-TRUS fusion-guided Rezūm therapy (Procedure): 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 outcomes

• Feasibility: Success rate defined by completion of cases [Peri-operative period]

Secondary outcomes

• Duration of operation [Intra-operation]: The time between scope in and scope out
• 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 [Peri-operative period]: Duration of hospital stay in hour since completion of operation
• 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 [Month 1]: The severity of AE is grade by Clavien-Dindo classification.
• Hospital readmission rate since completion of the operation [Month 1]
• Urinary symptoms measured by International Prostate Symptom Score (IPSS) score [Baseline and Month 3]: Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom
• Change in voiding function in uroflowmetry [Baseline and Month 3]: It is assessed by maximum flow rate and post void volume in uroflowmetry
• Prostate size [Baseline and Month 3]: Assessed by transrectal ultrasound

Sex: Male, ages: 30 Years to 80 Years

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.

• 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