BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Not Applicable

Recruiting

• Conditions: Prostate Hyperplasia
• Interventions: Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH

• Registration Number: NCT05443451
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-05
• Study Start: 2022-09-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transperineal Microwave needle ablation for symptomatic BPH	3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AE) and serious adverse events (SAE) related to the treatment	At 1 month	The severity of AE is grade by Clavien-Dindo classification.

Secondary Outcome Measures

Name	Time	Method
Ablation treatment time	Intra-operation	Duration of the ablation procedure
Ease of the procedure measured with a score chosen by the operator	Post procedure immediately	1: easy, 2: moderate, 3: difficult
Patient quality of life	Baseline, 1-week, 1-month, 3-month, and 6-month,	Assessed with the EQ-5D-5L questionnaire, the higher the score the better in quality of life
Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score	Baseline, 1 month, 3 months, 6 months	Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom.
Change in urodynamic in uroflowmetry	Baseline, 1 month, 3 months, 6 months	Change in urodynamic function assessed by uroflowmetry, parameters include voided volume, maximum flow rate and post-void residual.
Average patient post-operative pain level	Baseline, 2 and 4 hours after the procedure and at 1-week	Assessed by a pain numeric rating scale, Score 0-10, the higher score the worsen pain
Prostate volume change	Baseline, 3 months, 6 months	Prostate volume change after treatment
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score	Baseline, 1 month, 3 months, 6 months	Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom.
Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score	Baseline, 1 month, 3 months, 6 months	Change in MSHQ-EjD-SF questionnaire score (Range from 1-15 for function and and 0-5 for bother). The higher score, the more worse symptom.
PSA change	Baseline, 3 months, 6 months	PSA change after treatment
Patient satisfaction	Baseline, 1-week, 1-month, 3-month, and 6-month,	Assessed with the PGI-I questionnaire,the lower score the more satisfaction
Length of hospital stay	The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure]	Total number of days of hospitalization for the surgical procedure
Operation time	Intra-operation	Duration of patients stay in Operation Room

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong