Clinical trial NCT05443451: BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY
Official title: 3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Hyperplasia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Koelis
First posted: 2022-07-05
Enrollment: 12
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events (AE) and serious adverse events (SAE) related to the treatment
timeFrame: At 1 month
Secondary outcomes:
measure: Prostate volume change
timeFrame: Baseline, 3 months, 6 months
measure: Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in urodynamic in uroflowmetry
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: PSA change
timeFrame: Baseline, 3 months, 6 months
measure: Average patient post-operative pain level
timeFrame: Baseline, 2 and 4 hours after the procedure and at 1-week
measure: Patient quality of life
timeFrame: Baseline, 1-week, 1-month, 3-month, and 6-month,
measure: Patient satisfaction
timeFrame: Baseline, 1-week, 1-month, 3-month, and 6-month,
measure: Ease of the procedure measured with a score chosen by the operator
timeFrame: Post procedure immediately
measure: Ablation treatment time
timeFrame: Intra-operation
measure: Length of hospital stay
timeFrame: The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure]
measure: Operation time
timeFrame: Intra-operation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Peter Ka-Fung CHIU, FRCS, PhD
role: PRINCIPAL_INVESTIGATOR
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