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