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BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Primary Purpose

Prostate Hyperplasia

Status

Recruiting

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Prostate Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transperineal Microwave needle ablation for symptomatic BPH

Arm Description

Outcomes

Primary Outcome Measures

Adverse events (AE) and serious adverse events (SAE) related to the treatment

The severity of AE is grade by Clavien-Dindo classification.

Secondary Outcome Measures

Prostate volume change

Prostate volume change after treatment

Urinary symptoms measured by International Prostate Symptom Score (IPSS) score

Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom.

Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score

Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom.

Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score

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.

Change in urodynamic in uroflowmetry

Change in urodynamic function assessed by uroflowmetry, parameters include voided volume, maximum flow rate and post-void residual.

PSA change

PSA change after treatment

Average patient post-operative pain level

Assessed by a pain numeric rating scale, Score 0-10, the higher score the worsen pain

Patient quality of life

Assessed with the EQ-5D-5L questionnaire, the higher the score the better in quality of life

Patient satisfaction

Assessed with the PGI-I questionnaire,the lower score the more satisfaction

Ease of the procedure measured with a score chosen by the operator

1: easy, 2: moderate, 3: difficult

Ablation treatment time

Duration of the ablation procedure

Length of hospital stay

Total number of days of hospitalization for the surgical procedure

Operation time

Duration of patients stay in Operation Room

Full Information

NCT ID

NCT05443451

First Posted

June 22, 2022

Last Updated

February 8, 2023

Sponsor

Chinese University of Hong Kong

Collaborators

Koelis

1. Study Identification

Unique Protocol Identification Number

NCT05443451

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 8, 2022 (Actual)

Primary Completion Date

August 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

Collaborators

Koelis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transperineal Microwave needle ablation for symptomatic BPH

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

The procedure will consist of a focal, transperineal, targeted microwave ablation of prostate adenoma. Surgical planning using 3D transrectal ultrasound and real-time monitoring of the ablation would preserve key anatomical landmarks such as the bladder neck, prostatic urethra and verumontanum. The Organ-Based Tracking (OBT®) patented technology would provide a 3D prostate model to facilitate real-time navigation-guided ablation and accurate mapping of treatment zone. The procedure will be conducted under general anaesthesia, spinal anaesthesia, or monitored anaesthetic care / sedation. An average number of one to three microwave ablations per lobe is expected, depending on the size and shape of each prostate. The microwave ablation parameters will be chosen intraoperatively. A urinary catheter may be necessary immediately after the procedure. Patients are planned to be discharged on the same day or the day after when they are fit for discharge.

Primary Outcome Measure Information:

Title

Adverse events (AE) and serious adverse events (SAE) related to the treatment

Description

The severity of AE is grade by Clavien-Dindo classification.

Time Frame

At 1 month

Secondary Outcome Measure Information:

Title

Prostate volume change

Description

Prostate volume change after treatment

Time Frame

Baseline, 3 months, 6 months

Title

Urinary symptoms measured by International Prostate Symptom Score (IPSS) score

Description

Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom.

Time Frame

Baseline, 1 month, 3 months, 6 months

Title

Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score

Description

Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom.

Time Frame

Baseline, 1 month, 3 months, 6 months

Title

Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score

Description

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.

Time Frame

Baseline, 1 month, 3 months, 6 months

Title

Change in urodynamic in uroflowmetry

Description

Change in urodynamic function assessed by uroflowmetry, parameters include voided volume, maximum flow rate and post-void residual.

Time Frame

Baseline, 1 month, 3 months, 6 months

Title

PSA change

Description

PSA change after treatment

Time Frame

Baseline, 3 months, 6 months

Title

Average patient post-operative pain level

Description

Assessed by a pain numeric rating scale, Score 0-10, the higher score the worsen pain

Time Frame

Baseline, 2 and 4 hours after the procedure and at 1-week

Title

Patient quality of life

Description

Assessed with the EQ-5D-5L questionnaire, the higher the score the better in quality of life

Time Frame

Baseline, 1-week, 1-month, 3-month, and 6-month,

Title

Patient satisfaction

Description

Assessed with the PGI-I questionnaire,the lower score the more satisfaction

Time Frame

Baseline, 1-week, 1-month, 3-month, and 6-month,

Title

Ease of the procedure measured with a score chosen by the operator

Description

1: easy, 2: moderate, 3: difficult

Time Frame

Post procedure immediately

Title

Ablation treatment time

Description

Duration of the ablation procedure

Time Frame

Intra-operation

Title

Length of hospital stay

Description

Total number of days of hospitalization for the surgical procedure

Time Frame

The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure]

Title

Operation time

Description

Duration of patients stay in Operation Room

Time Frame

Intra-operation

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male with prostate

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Ka-Fung CHIU, FRCS, PhD

Phone

3505-2625

peterchiu@surgery.cuhk.eud.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Ka-Fung CHIU, FRCS, PhD

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prince of Wales Hospital

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ka Fung Peter CHIU, FRCS, PhD

peterchiu@surgery.cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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31221864

Citation

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BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

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