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
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
Connect with a study center
Prince of Wales Hospital
Hong Kong,
Hong KongActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.