Actively Recruiting

Phase Not Applicable
Age: 50Years +
MALE
NCT05443451

BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Led by Chinese University of Hong Kong · Updated on 2025-05-06

12

Participants Needed

1

Research Sites

185 weeks

Total Duration

On this page

Sponsors

C

Chinese University of Hong Kong

Lead Sponsor

K

Koelis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Who Can Participate

Age: 50Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 50 years
  • Benign prostatic hyperplasia with prostate size 30-80 cc
  • International Prostate Symptom Score (IPSS) of 14 or higher
  • Prostate-specific antigen (PSA) 4 ng/mL or less, or PSA above 4 ng/mL with no suspicious lesion on mpMRI
  • Maximum urine flow rate (Qmax) 15 mL/s or less
  • Post-void residual urine volume 150 mL or less
  • Suitable for intravenous sedation, spinal anesthesia, or general anesthesia and focal microwave ablation
  • Able to provide informed written consent
Not Eligible

You will not qualify if you...

  • 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, or bladder tumor
  • History of long-term indwelling catheter
  • Urethral stricture
  • Known coagulopathy or use of anticoagulants
  • Presence of a pacemaker
  • Active infection
  • Dysuria caused by bladder dysfunction
  • Serious medical illness such as uncontrolled congestive heart failure, uncontrolled angina, recent myocardial infarction or cerebrovascular event within 6 months
  • Neurological disorders affecting bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury)
  • Contraindications for mpMRI exam or MR contrast
  • Acute or chronic renal failure with GFR less than 50 ml/min and serum creatinine over 1.5 mg/dL
  • Currently participating in another interventional clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

P

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY | DecenTrialz