BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Last updated: January 21, 2024
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 general anaesthesiaand 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 congestive heartfailure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6months 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:
December 31, 2024

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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