Phase
Condition
Prostate Disorders
Benign Prostatic Hyperplasia (Enlarged Prostate)
Treatment
3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH
Clinical Study ID
Ages > 50 Male
Study Summary
Eligibility Criteria
Inclusion
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 generalanaesthesia and focal microwave ablation.
Informed written consent
Exclusion
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 congestiveheart failure, uncontrolled angina, myocardial infarction, cerebrovascular eventwithin 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.
Study Design
Study Description
Connect with a study center
Prince of Wales Hospital
Hong Kong,
Hong KongActive - Recruiting
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