RecruitingNot ApplicableNCT05443451

BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia

Sponsor

Chinese University of Hong Kong

Enrollment

12 participants

Start Date

Sep 8, 2022

Study Type

INTERVENTIONAL

Conditions

Prostate Hyperplasia

Summary

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

Eligibility

Sex: MALEMin Age: 50 Years

Inclusion Criteria8

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 Criteria16

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICE3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH

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.