BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Last updated: May 4, 2025
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Benign Prostatic Hyperplasia (Enlarged Prostate)

Treatment

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

Clinical Study ID

NCT05443451
CRE 2022.249
  • Ages > 50
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

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 generalanaesthesia and focal microwave ablation.

  • Informed written consent

Exclusion

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 congestiveheart failure, uncontrolled angina, myocardial infarction, cerebrovascular eventwithin 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 Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH
Phase:
Study Start date:
September 08, 2022
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

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