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BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05443451
Collaborator
Koelis (Industry)
12
Enrollment
1
Location
1
Arm
28
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transperineal Microwave needle ablation for symptomatic BPH

Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Prostate volume change [Baseline, 3 months, 6 months]

    Prostate volume change after treatment

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. PSA change [Baseline, 3 months, 6 months]

    PSA change after treatment

  7. 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

  8. 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

  9. Patient satisfaction [Baseline, 1-week, 1-month, 3-month, and 6-month,]

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

  10. Ease of the procedure measured with a score chosen by the operator [Post procedure immediately]

    1: easy, 2: moderate, 3: difficult

  11. Ablation treatment time [Intra-operation]

    Duration of the ablation procedure

  12. 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

  13. Operation time [Intra-operation]

    Duration of patients stay in Operation Room

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prince of Wales Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong
  • Koelis

Investigators

  • Principal Investigator: Peter Ka-Fung CHIU, FRCS, PhD, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
CHIU Ka Fung Peter, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05443451
Other Study ID Numbers:
  • CRE 2022.249
First Posted:
Jul 5, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia

Study Results

No Results Posted as of Jul 5, 2022