This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).
Who can participate
Age range50 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Adverse events (AE) and serious adverse events (SAE) related to the treatment