Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. .
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI-TRUS fusion water vapour ablation | Experimental | The intervenitons will consist of MRI segmentation and image-informed injection planning, with documentation of planned and delivered injection sites and performance metrics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Success rate defined by completion of cases | Peri-operative period |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of operation | The time between scope in and scope out | Intra-operation |
| Duration of Software fusion time | Intra-operation | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinyang Alex Liu, MBBS, MSc, FRCSEd | Contact | 852+35052625 | alexliu@surgery.cuhk.edu.hk | |
| Hong Tim Lau, MSc | Contact | 852+35053933 | timlau@surgery.cuhk.edu.hk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | 999077 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33415211 | Background | 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. | |
| 29527813 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| North District Hospital | Sheung Shui | Hong Kong |
|
| Alice Ho Miu Ling Nethersole Hospital | Tai Po | Hong Kong |
|
| D052801 |
| Male Urogenital Diseases |