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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Prince of Wales Hospital
Shatin, Hong Kong
North District Hospital
Sheung Shui, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Feasibility: Success rate defined by completion of cases
Time frame: Peri-operative period
Duration of operation
The time between scope in and scope out
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
Duration of hospital stay in hour since completion of operation
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
The severity of AE is grade by Clavien-Dindo classification.
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
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom
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Time frame: Baseline and Month 3
Change in voiding function in uroflowmetry
It is assessed by maximum flow rate and post void volume in uroflowmetry
Time frame: Baseline and Month 3
Prostate size
Assessed by transrectal ultrasound
Time frame: Baseline and Month 3