Actively Recruiting

Phase Not Applicable
Age: 50Years +
MALE
ID05443451

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

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

12

Participants Needed

1

Research Sites

12 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

Researchers are studying a new treatment called 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH). This pilot study is designed as a prospective, single-center, open-label trial involving 12 patients. The goal is to assess the safety and effects of this targeted microwave therapy on enlarged prostate symptoms. The treatment involves a focal, transperineal microwave ablation of prostate adenoma guided by 3D ultrasound and real-time monitoring to protect important anatomical areas. The procedure may use general anesthesia, spinal anesthesia, or sedation based on patient needs. One to three ablations per prostate lobe are expected, tailored during the operation. A urinary catheter might be needed right after the procedure, and patients are typically discharged the same or next day. Participants will be followed closely for six months after treatment. Researchers will track safety by monitoring adverse events one month after the procedure. They will also measure changes in prostate size, urinary symptoms, sexual function, urine flow, PSA levels, pain, quality of life, patient satisfaction, and procedure details at various time points up to six months. Hospital stay length and operation time will also be recorded.

CONDITIONS

Brief 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) level 4 ng/mL or lower, or higher PSA 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 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 blood clotting disorders or use of anticoagulant medication
  • Presence of a pacemaker
  • Active infection
  • Urinary discomfort due to bladder dysfunction
  • Serious medical illness including uncontrolled heart failure, angina, recent heart attack, or stroke within 6 months
  • Neurological disorders affecting bladder function such as multiple sclerosis, Parkinson's disease, or spinal cord injury
  • Contraindications for mpMRI exam or MRI contrast
  • Acute or chronic kidney failure with low filtration rate or high creatinine
  • 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants undergo a targeted transperineal microwave needle ablation procedure guided by 3D ultrasound to treat benign prostatic hyperplasia. The procedure is performed under anesthesia and may require a urinary catheter immediately after. Participants are typically discharged the same day or the next day after recovery.

1 visit (procedure day)

Post-operative Follow-up

Duration - Up to 6 months

Participants are closely followed for safety and efficacy with assessments including urinary symptoms, prostate volume, erectile and ejaculatory function, urodynamics, PSA levels, pain levels, quality of life, and satisfaction.

Multiple visits at 1 week, 1 month, 3 months, and 6 months

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

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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Published Research Related To This Trial

Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study.

Weiyu Zhang, Xiaopeng Zhang, Haibin Li...

https://pubmed.ncbi.nlm.nih.gov/31221864

The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study.

Claus G Roehrborn, Paul Siami, Jack Barkin...

https://pubmed.ncbi.nlm.nih.gov/19825505

Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection.

Chi-hang Yee, Joseph Hon-ming Wong, Peter Ka-fung Chiu...

https://pubmed.ncbi.nlm.nih.gov/26042336

Reoperation, myocardial infarction and mortality after transurethral and open prostatectomy: a nation-wide, long-term analysis of 23,123 cases.

Stephan Madersbacher, Jakob Lackner, Clemens Brössner...

https://pubmed.ncbi.nlm.nih.gov/15774249

The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial.

Bilal Chughtai, Dean Elterman, Neal Shore...

https://pubmed.ncbi.nlm.nih.gov/33373708

Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Kevin T McVary, Marc C Gittelman, Kenneth A Goldberg...

https://pubmed.ncbi.nlm.nih.gov/33872051

Sectoral cancer detection and tolerability of freehand transperineal prostate biopsy under local anaesthesia.

Peter Ka-Fung Chiu, Ka-Lun Lo, Jeremy Yuen-Chun Teoh...

https://pubmed.ncbi.nlm.nih.gov/32999465

Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial.

Nicolas Barry Delongchamps, Alexandre Schull, Julien Anract...

https://pubmed.ncbi.nlm.nih.gov/34260598