Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Water vapor thermal therapy
Brief 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).
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
PROCEDUREMRI-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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: Success rate defined by completion of cases | Peri-operative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hong Kong
Contacts
CONTACTQinyang Alex Liu, MBBS, MSc, FRCSEd
CONTACTHong Tim Lau, MSc
Outcome results
None listed