This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
Prince of Wales Hospital
Hong Kong, Hong Kong
Adverse events (AE) and serious adverse events (SAE) related to the treatment
The severity of AE is grade by Clavien-Dindo classification.
Time frame: At 1 month
Prostate volume change
Prostate volume change after treatment
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 month, 3 months, 6 months
PSA change
PSA change after treatment
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Time frame: 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
Time frame: 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
Time frame: Baseline, 1-week, 1-month, 3-month, and 6-month,
Patient satisfaction
Assessed with the PGI-I questionnaire,the lower score the more satisfaction
Time frame: 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
Time frame: Post procedure immediately
Ablation treatment time
Duration of the ablation procedure
Time frame: Intra-operation
Length of hospital stay
Total number of days of hospitalization for the surgical procedure
Time frame: 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
Time frame: Intra-operation