BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Study Overview
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Brief Summary
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This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).

Detailed Description
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This is a prospective, single centre, open-label and non-comparative trial planned on 12 patients. Patients who fit inclusion criteria would be recruited and offered microwave ablation to the enlarged prostate. The patients will be closely followed up to 6 months after treatment with serial assessment on safety and efficacy.

Official Title
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3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia

Conditions
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Prostate Hyperplasia

Intervention / Treatment
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* Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 50 years. Benign prostatic hyperplasia with prostate size 30-80 cc IPSS ≥ 14 PSA ≤ 4 ng/mL or PSA >4 ng/mL with no evidence of suspicious lesion on mpMRI Maximum urine flow rate (Qmax) ≤ 15 mL/s. Post-Void Residual ≤ 150 mL. Patient suitable for IV sedation and/or spinal anaesthesia and/or general anaesthesia and focal microwave ablation. Informed written consent Exclusion Criteria: Significant intravesical median lobe hyperplasia. Suspicious lesion on mpMRI prostate History of prostate, bladder or urethral surgery. History of prostate cancer Presence of stones, bladder diverticulum and/or bladder tumor History of long-term indwelling catheter. Urethral stricture Known coagulopathy or on anticoagulant Presence of a pacemaker. Active infection Dysuria due to bladder dysfunction. Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit. Neurological disorders that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury). Contraindications for mpMRI exam or MR contrast Acute and/or chronic renal failure (GFR <50 ml/min and serum creatinine > 1.5 mg/d). Patient currently participating in another interventional clinical trial.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transperineal Microwave needle ablation for symptomatic BPH<br> | Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH<br>* The procedure will consist of a focal, transperineal, targeted microwave ablation of prostate adenoma. Surgical planning using 3D transrectal ultrasound and real-time monitoring of the ablation would preserve key anatomical landmarks such as the bladder neck, prostatic urethra and verumontanum. The Organ-Based Tracking (OBT®) patented technology would provide a 3D prostate model to facilitate real-time navigation-guided ablation and accurate mapping of treatment zone. The procedure will be conducted under general anaesthesia, spinal anaesthesia, or monitored anaesthetic care / sedation. An average number of one to three microwave ablations per lobe is expected, depending on the size and shape of each prostate. The microwave ablation parameters will be chosen intraoperatively. A urinary catheter may be necessary immediately after the procedure. Patients are planned to be discharged on the same day or the day after when they are fit for discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AE) and serious adverse events (SAE) related to the treatment | The severity of AE is grade by Clavien-Dindo classification. | At 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate volume change | Prostate volume change after treatment | Baseline, 3 months, 6 months | 
| 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, 1 month, 3 months, 6 months | 
| Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score | Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom. | Baseline, 1 month, 3 months, 6 months | 
| Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score | Change in MSHQ-EjD-SF questionnaire score (Range from 1-15 for function and and 0-5 for bother). The higher score, the more worse symptom. | Baseline, 1 month, 3 months, 6 months | 
| Change in urodynamic in uroflowmetry | Change in urodynamic function assessed by uroflowmetry, parameters include voided volume, maximum flow rate and post-void residual. | Baseline, 1 month, 3 months, 6 months | 
| PSA change | PSA change after treatment | Baseline, 3 months, 6 months | 
| Average patient post-operative pain level | Assessed by a pain numeric rating scale, Score 0-10, the higher score the worsen pain | Baseline, 2 and 4 hours after the procedure and at 1-week | 
| Patient quality of life | Assessed with the EQ-5D-5L questionnaire, the higher the score the better in quality of life | Baseline, 1-week, 1-month, 3-month, and 6-month, | 
| Patient satisfaction | Assessed with the PGI-I questionnaire,the lower score the more satisfaction | Baseline, 1-week, 1-month, 3-month, and 6-month, | 
| Ease of the procedure measured with a score chosen by the operator | 1: easy, 2: moderate, 3: difficult | Post procedure immediately | 
| Ablation treatment time | Duration of the ablation procedure | Intra-operation | 
| Length of hospital stay | Total number of days of hospitalization for the surgical procedure | The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure] | 
| Operation time | Duration of patients stay in Operation Room | Intra-operation |