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Neuflo System for the Treatment of BPH

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuflo BPH Treatment System
Sponsored by
ProstaCare Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring prostate, catheter, IPSS

Eligibility Criteria

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

Inclusion Criteria: Participants must meet all inclusion criteria to participate in this study. Males aged 45 years of age or older IPSS score of 12 or higher Diagnosis of BPH in their medical records Eligible uroflow with unadjusted or adjusted peak flow rate of equal to or less than 13ml/sec with a corresponding: voided volume of at least 100 ml, and, Post Void Residual (PVR) of 250 ml or less Prostate volume of 25-55 cm3, inclusive as measured by ultrasound or MRI Prostatic sagittal length of 3.2 cm or greater, as measured by ultrasound or MRI Prostatic transverse width of 3.5 cm or greater as measured by ultrasound or MRI Prostatic anterior-posterior height of 2.5 cm or greater as measured by ultrasound or MRI Participant must have the ability to understand and consent to participate in this study Participant must be willing and able to participate in follow-up evaluations Exclusion Criteria: Participants meeting any of the exclusion criteria listed at baseline will be excluded from participation. Outlet obstruction due to an enlarged middle lobe or significant central gland of the prostate Significant transverse asymmetry of prostatic lateral lobes Participant has an implantable pacemaker or cardiac defibrillator Participant has a penile implant History or current diagnosis of prostate cancer or bladder cancer Active urinary tract infection (UTI) (Note: participant can be enrolled if the UTI is treated and followed with a negative urine test result) Neurogenic, decompensated, or atonic bladder Overactive bladder in the absence of prostatic obstruction Current, recurrent (two or more) urethral strictures or muscle spasms that prevent insertion of the catheter Bleeding disorders or takes anticoagulation medications unless anti-platelet medication has been discontinued for at least 7 days prior to treatment (Participants are allowed to delay or repeat screening to fulfil this requirement) Previous rectal surgery other than haemorrhoidectomy Previous radical pelvic surgery or pelvic irradiation Interest in maintaining fertility Previous surgery or minimally invasive procedure(s) to treat symptomatic BPH Use of Alpha blocker for the treatment of BPH within 14 days of treatment date. (Participants are allowed to delay or repeat screening to fulfil this requirement) 5-ARI (5-alpha-reductase inhibitor), (an enzyme inhibitor) use within 3 months of treatment date (Participants are allowed to delay screening to fulfil this requirement) Concomitant bladder stones History of other diseases or conditions causing voiding dysfunction Current medication affecting bladder function Known allergy to nickel Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months History of medical, surgical, or other conditions that, in the opinion of the investigator, would limit study participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants receiving treatment with the Neuflo BPH Treatment System.

    Arm Description

    Outcomes

    Primary Outcome Measures

    Effectiveness: Relief of BPH symptoms as measured by international prostate symptom score (IPSS)
    Percent change in IPSS score between baseline and 3 months

    Secondary Outcome Measures

    Improvement in urinary function, sexual function, and quality of life
    Change in Maximum Flow Rate (Qmax), Post Void Residual (PVR), International Index of Erectile Function (IIEF) and Quality of Life (QoL) between baseline and 3 months.
    Treatment tolerability & procedural medication requirements
    Visual Analog Scale Visual Analog Scale Visual Analog Scale (VAS) pain and medications required before, during and after treatment
    Secondary intervention and medication use for Lower Urinary Tract Symptoms (LUTS)
    Document use of secondary intervention for treatment of LUTS and medication requirements at follow up visits beyond 6 weeks.
    Neuflo System performance
    Frequency of system deficiencies including adverse events during treatment.
    Change in prostate volume
    Measurement of change in prostate volume between baseline and 3 and 12 months after treatment using MRI.
    Maintenance of improvement of LUTS
    Percent change in IPSS score between baseline and 12 months after treatment
    Participant satisfaction
    Participant satisfaction score (satisfied with the procedure)

    Full Information

    First Posted
    May 23, 2023
    Last Updated
    May 23, 2023
    Sponsor
    ProstaCare Pty Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05884580
    Brief Title
    Neuflo System for the Treatment of BPH
    Official Title
    Neuflo Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ProstaCare Pty Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The goal of this clinical study is to assess the effectiveness and safety of the Neuflo System for the treatment of benign prostatic hyperplasia (BPH). The main questions it aims to answer are: Can treatment with the Neuflo System lead to at least a 30% improvement in lower urinary tract symptoms (LUTS) secondary to BPH, as measured by the international prostate symptom score (IPSS) at 3 months after treatment which is sustained for 12 months? Is treatment with the Neuflo System tolerable to the patient, as measured by visual analog score (VAS) for pain before and after treatment and procedural medication requirements? Is treatment with the Neuflo System safe, as measured by the incidence and severity of device or procedural related serious adverse events. Participants will be enrolled in the study over a 6 month period. Each participant will be treated with the Neuflo System and assessed at 3 and 12 months following treatment. A subgroup of patients will have an MRI at baseline (prior to treatment), and 1 and 3 months following treatment to assess the volume and location of ablated tissue. The duration of the study is expected to be 18 months.
    Detailed Description
    This is a prospective, multicentre, single-arm clinical study in a sample of up to 25 participants across study sites in Australia and New Zealand. The aim of the study is to assess the effectiveness and safety of treatment with the Neuflo BPH Treatment System to relieve lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BPH is characterised by the benign growth of stromal and epithelial cells around the prostatic urethra causing obstruction and LUTS which include urinary retention, frequent urination, dysuria, nocturia, and increased risk of urinary tract infections. Although BPH is a benign condition, the resulting symptoms can greatly reduce quality of life. The Neuflo System uses water electrolysis and the associated changes in pH to ablate the prostate cells in the region surrounding electrodes which are placed into the tissue via the urethra. The shaft of the Neuflo device is inserted by the clinician into the urethra within a Foley catheter which has been anchored in the bladder. The device is operated using a handle attached to a battery-powered control unit which provides a low level charge. When the tip of the shaft is positioned adjacent to the prostate, the clinician deploys four small electrodes which move through the Foley catheter and urethral wall into the prostate. The clinician then starts the treatment using the control unit. The control unit delivers a defined current for a defined duration and turns off automatically. The electrodes are then retracted and the device removed. The Foley catheter may be removed or remain according to clinical needs. The treatment process is not expected to cause any more than mild discomfort and be completed within 30 minutes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
    Keywords
    prostate, catheter, IPSS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective, multicentre, single-arm clinical evaluation
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants receiving treatment with the Neuflo BPH Treatment System.
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Neuflo BPH Treatment System
    Other Intervention Name(s)
    Neuflo Water Hydrolysis System
    Intervention Description
    The Neuflo BPH Treatment System is designed to treat patients with lower urinary tract symptoms (LUTS) associated with BPH. It is an outpatient-based, minimally invasive treatment option and uses hydrolysis to reduce prostatic tissue in the lateral lobes of the prostate. Reduced pressure and constriction of the urethra alleviates urinary and other symptoms of BPH.
    Primary Outcome Measure Information:
    Title
    Effectiveness: Relief of BPH symptoms as measured by international prostate symptom score (IPSS)
    Description
    Percent change in IPSS score between baseline and 3 months
    Time Frame
    3 months after treatment
    Secondary Outcome Measure Information:
    Title
    Improvement in urinary function, sexual function, and quality of life
    Description
    Change in Maximum Flow Rate (Qmax), Post Void Residual (PVR), International Index of Erectile Function (IIEF) and Quality of Life (QoL) between baseline and 3 months.
    Time Frame
    At 3 months after treatment
    Title
    Treatment tolerability & procedural medication requirements
    Description
    Visual Analog Scale Visual Analog Scale Visual Analog Scale (VAS) pain and medications required before, during and after treatment
    Time Frame
    On day of treatment only
    Title
    Secondary intervention and medication use for Lower Urinary Tract Symptoms (LUTS)
    Description
    Document use of secondary intervention for treatment of LUTS and medication requirements at follow up visits beyond 6 weeks.
    Time Frame
    At 3, 6 and12 months after treatment
    Title
    Neuflo System performance
    Description
    Frequency of system deficiencies including adverse events during treatment.
    Time Frame
    On day of treatment only
    Title
    Change in prostate volume
    Description
    Measurement of change in prostate volume between baseline and 3 and 12 months after treatment using MRI.
    Time Frame
    At 3 and 12 months after treatment
    Title
    Maintenance of improvement of LUTS
    Description
    Percent change in IPSS score between baseline and 12 months after treatment
    Time Frame
    At 12 months after treatment
    Title
    Participant satisfaction
    Description
    Participant satisfaction score (satisfied with the procedure)
    Time Frame
    1 and 6 weeks, and 3, 6 and 12 months after treatment
    Other Pre-specified Outcome Measures:
    Title
    Safety: safety of the Neuflo System
    Description
    Incidence and severity of device and/or procedural serious adverse events
    Time Frame
    Up to 12 months after treatment

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must meet all inclusion criteria to participate in this study. Males aged 45 years of age or older IPSS score of 12 or higher Diagnosis of BPH in their medical records Eligible uroflow with unadjusted or adjusted peak flow rate of equal to or less than 13ml/sec with a corresponding: voided volume of at least 100 ml, and, Post Void Residual (PVR) of 250 ml or less Prostate volume of 25-55 cm3, inclusive as measured by ultrasound or MRI Prostatic sagittal length of 3.2 cm or greater, as measured by ultrasound or MRI Prostatic transverse width of 3.5 cm or greater as measured by ultrasound or MRI Prostatic anterior-posterior height of 2.5 cm or greater as measured by ultrasound or MRI Participant must have the ability to understand and consent to participate in this study Participant must be willing and able to participate in follow-up evaluations Exclusion Criteria: Participants meeting any of the exclusion criteria listed at baseline will be excluded from participation. Outlet obstruction due to an enlarged middle lobe or significant central gland of the prostate Significant transverse asymmetry of prostatic lateral lobes Participant has an implantable pacemaker or cardiac defibrillator Participant has a penile implant History or current diagnosis of prostate cancer or bladder cancer Active urinary tract infection (UTI) (Note: participant can be enrolled if the UTI is treated and followed with a negative urine test result) Neurogenic, decompensated, or atonic bladder Overactive bladder in the absence of prostatic obstruction Current, recurrent (two or more) urethral strictures or muscle spasms that prevent insertion of the catheter Bleeding disorders or takes anticoagulation medications unless anti-platelet medication has been discontinued for at least 7 days prior to treatment (Participants are allowed to delay or repeat screening to fulfil this requirement) Previous rectal surgery other than haemorrhoidectomy Previous radical pelvic surgery or pelvic irradiation Interest in maintaining fertility Previous surgery or minimally invasive procedure(s) to treat symptomatic BPH Use of Alpha blocker for the treatment of BPH within 14 days of treatment date. (Participants are allowed to delay or repeat screening to fulfil this requirement) 5-ARI (5-alpha-reductase inhibitor), (an enzyme inhibitor) use within 3 months of treatment date (Participants are allowed to delay screening to fulfil this requirement) Concomitant bladder stones History of other diseases or conditions causing voiding dysfunction Current medication affecting bladder function Known allergy to nickel Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months History of medical, surgical, or other conditions that, in the opinion of the investigator, would limit study participation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Flora Yuen
    Phone
    +61 2 9460 6688
    Ext
    3030
    Email
    flora.yeun@avaniaclinical.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charles Aznavoorian
    Phone
    +61 2 9460 6688
    Email
    charles.aznavoorian@avaniaclinical.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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