BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Prostate Hyperplasia

Treatments: Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05443451

CRE 2022.249

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Transperineal Microwave needle ablation for symptomatic BPH

Experimental group

Treatment:

Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH

Sponsors of this trial

Lead Sponsor

The Chinese University of Hong Kong

Collaborating Sponsor

KOELIS