BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

June 21, 2026 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transperineal Microwave needle ablation for symptomatic BPH
Device: 3D-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AE) and serious adverse events (SAE) related to the treatment
Time Frame: At 1 month
The severity of AE is grade by Clavien-Dindo classification.
At 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate volume change
Time Frame: Baseline, 3 months, 6 months
Prostate volume change after treatment
Baseline, 3 months, 6 months
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
Time Frame: Baseline, 1 month, 3 months, 6 months
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom.
Baseline, 1 month, 3 months, 6 months
Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score
Time Frame: Baseline, 1 month, 3 months, 6 months
Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom.
Baseline, 1 month, 3 months, 6 months
Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score
Time Frame: Baseline, 1 month, 3 months, 6 months
Change in MSHQ-EjD-SF questionnaire score (Range from 1-15 for function and and 0-5 for bother). The higher score, the more worse symptom.
Baseline, 1 month, 3 months, 6 months
Change in urodynamic in uroflowmetry
Time Frame: Baseline, 1 month, 3 months, 6 months
Change in urodynamic function assessed by uroflowmetry, parameters include voided volume, maximum flow rate and post-void residual.
Baseline, 1 month, 3 months, 6 months
PSA change
Time Frame: Baseline, 3 months, 6 months
PSA change after treatment
Baseline, 3 months, 6 months
Average patient post-operative pain level
Time Frame: Baseline, 2 and 4 hours after the procedure and at 1-week
Assessed by a pain numeric rating scale, Score 0-10, the higher score the worsen pain
Baseline, 2 and 4 hours after the procedure and at 1-week
Patient quality of life
Time Frame: Baseline, 1-week, 1-month, 3-month, and 6-month,
Assessed with the EQ-5D-5L questionnaire, the higher the score the better in quality of life
Baseline, 1-week, 1-month, 3-month, and 6-month,
Patient satisfaction
Time Frame: Baseline, 1-week, 1-month, 3-month, and 6-month,
Assessed with the PGI-I questionnaire,the lower score the more satisfaction
Baseline, 1-week, 1-month, 3-month, and 6-month,
Ease of the procedure measured with a score chosen by the operator
Time Frame: Post procedure immediately
1: easy, 2: moderate, 3: difficult
Post procedure immediately
Ablation treatment time
Time Frame: Intra-operation
Duration of the ablation procedure
Intra-operation
Length of hospital stay
Time Frame: The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure]
Total number of days of hospitalization for the surgical procedure
The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure]
Operation time
Time Frame: Intra-operation
Duration of patients stay in Operation Room
Intra-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Koelis

Investigators

  • Principal Investigator: Peter Ka-Fung CHIU, FRCS, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Actual)

October 5, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 21, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE 2022.249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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