Neuflo System for the Treatment of BPH

Sponsor

ProstaCare Pty Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05884580

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms	Device: Neuflo BPH Treatment System	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, multicentre, single-arm clinical evaluationProspective, multicentre, single-arm clinical evaluation

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neuflo Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants receiving treatment with the Neuflo BPH Treatment System.	Device: Neuflo BPH Treatment System 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. Other Names: Neuflo Water Hydrolysis System

Arm

Intervention/Treatment

Experimental: Participants receiving treatment with the Neuflo BPH Treatment System.

Device: Neuflo BPH Treatment System

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.

Other Names:

Neuflo Water Hydrolysis System

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement in urinary function, sexual function, and quality of life [At 3 months after treatment]
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 [On day of treatment only]
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) [At 3, 6 and12 months after treatment]
Document use of secondary intervention for treatment of LUTS and medication requirements at follow up visits beyond 6 weeks.
Neuflo System performance [On day of treatment only]
Frequency of system deficiencies including adverse events during treatment.
Change in prostate volume [At 3 and 12 months after treatment]
Measurement of change in prostate volume between baseline and 3 and 12 months after treatment using MRI.
Maintenance of improvement of LUTS [At 12 months after treatment]
Percent change in IPSS score between baseline and 12 months after treatment
Participant satisfaction [1 and 6 weeks, and 3, 6 and 12 months after treatment]
Participant satisfaction score (satisfied with the procedure)

Other Outcome Measures

Safety: safety of the Neuflo System [Up to 12 months after treatment]
Incidence and severity of device and/or procedural serious adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts 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