Benign Prostatic HyperplasiaNCT05884580
Neuflo System for the Treatment of BPH
A study testing Neuflo BPH Treatment System in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by ProstaCare Pty Ltd at 1 site in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Neuflo BPH Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNew Zealand
- Study dates
- 10 Nov 2023to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all inclusion criteria to participate in this study.
- Males aged 45 years of age or older
- IPSS score of 13 or higher
- 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
Show all 12Show fewer
- Prostate volume of 25-80 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuflo Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia
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.
Read more
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 1 week to assess the volume and location of ablated tissue.
The duration of the study is expected to be 18 months.
Read the 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.
- Being tested
- Neuflo BPH Treatment System
- Keywords
- prostate, catheter, IPSS
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuflo BPH Treatment SystemDevice
Also called Neuflo Water Hydrolysis 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.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving treatment with the Neuflo BPH Treatment System. | Experimental | Not described Receives: Device: Neuflo BPH Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Relief of BPH symptoms as measured by International Prostate Symptom Score (IPSS)
Participants IPSS scores have a possible range of 13 to 35 with higher scores indicating more severe symptoms. Effective relief of BPH symptoms will be indicated by improvement (reduction) at 3 months of at least 30% from baseline IPSS score.
Measured: 3 months after treatment
Secondary outcomes (10)
Improvement in urinary function (Qmax)
Urinary Flow rate is measured in ml per second with higher flow rate indicating superior urinary function. Improvement in urinary function will be indicated by increased Maximum Flow Rate (Qmax) at 3 months relative to baseline.
Measured: At 3 months after treatment
Improvement in urinary function (PVR)
Post Void Residual (PVR) is a measure of the amount of urine left in the bladder after a voluntary void and is measured in ml. Improvement in urinary function will be indicated by reduced PVR at 3 months relative to baseline.
Measured: At 3 months after treatment
Improvement in sexual function
Sexual function will be measured using the International Index of Erectile Function (IIEF) where lower scores indicate worse erectile dysfunction. Improvement in sexual function will be indicated by higher scores on the IIEF at 3 months relative to baseline.
Measured: At 3 months after treatment
Improvement in quality of life
Quality of Life due to urinary symptoms (QoL) measured on a scale of 0 to 7 with higher scores indicating worse quality of life. Improvement in QoL indicated by a lower score at 3 months relative to baseline.
Measured: At 3 months after treatment
Treatment tolerability & procedural medication requirements
Visual Analog Scale (VAS) to measure pain before, during, and immediately following treatment. VAS to measure pain from 0 to 10 with higher scores indicating more pain. Procedural medication requirements to be captured in instances where medication is used.
Measured: On day of treatment only
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.
Measured: At 3, 6 and12 months after treatment
Neuflo System performance
Frequency of system deficiencies including adverse events during treatment.
Measured: On day of treatment only
Neuflo System performance on Larger Prostates
Comparison of primary outcome on 56cm3 to 80cm3 prostates relative to 25cm3 to 55cm3 prostates
Measured: At 3 months after treatment
Maintenance of improvement of LUTS
Percent change in IPSS score between baseline and 12 months after treatment.
Measured: At 12 months after treatment
Participant satisfaction
Participant satisfaction score (satisfied with the procedure) measured on a 5 point scale with higher scores indicating greater satisfaction.
Measured: 1 and 6 weeks, and 3, 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start10 Nov 2023
- Primary completion9 Jan 2026
- Study completion10 Jan 2026
Why it stopped: A design change was required following the first treatment. The design concept was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicentre, single-arm clinical evaluation
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProstaCare Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884580
- Sponsor's protocol ID
- Neuflo-CIP-ANZ-202303
- Status last verified
- Feb 2026
- First submitted
- 23 May 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuflo Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT05884580
- Acronym / sponsor ID
- Neuflo-CIP-ANZ-202303
- Keywords
- prostate, catheter, IPSS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A design change was required following the first treatment. The design concept was not feasible.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ProstaCare Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1 week 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicentre, single-arm clinical evaluation
| Arm | Type | Receives |
|---|---|---|
| Participants receiving treatment with the Neuflo BPH Treatment System. | Experimental | Device: Neuflo BPH Treatment System |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants must meet all inclusion criteria to participate in this study.
- Males aged 45 years of age or older
- IPSS score of 13 or higher
- Eligible uroflow with unadjusted or adjusted peak flow rate of equal to or less than 13ml/sec with a corresponding:
- Prostate volume of 25-80 cm3, inclusive as measured by ultrasound or MRI
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuflo BPH Treatment SystemAlso: Neuflo Water Hydrolysis SystemThe 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. | Device | Participants receiving treatment with the Neuflo BPH Treatment System. |
Primary outcome
Effectiveness: Relief of BPH symptoms as measured by International Prostate Symptom Score (IPSS)
Time frame: 3 months after treatment
Participants IPSS scores have a possible range of 13 to 35 with higher scores indicating more severe symptoms. Effective relief of BPH symptoms will be indicated by improvement (reduction) at 3 months of at least 30% from baseline IPSS score.
10 secondary outcomes
Improvement in urinary function (Qmax)
Time frame: At 3 months after treatment
Improvement in urinary function (PVR)
Time frame: At 3 months after treatment
Improvement in sexual function
Time frame: At 3 months after treatment
Improvement in quality of life
Time frame: At 3 months after treatment
Treatment tolerability & procedural medication requirements
Time frame: On day of treatment only
Secondary intervention and medication use for Lower Urinary Tract Symptoms (LUTS)
Time frame: At 3, 6 and12 months after treatment
Neuflo System performance
Time frame: On day of treatment only
Neuflo System performance on Larger Prostates
Time frame: At 3 months after treatment
Maintenance of improvement of LUTS
Time frame: At 12 months after treatment
Participant satisfaction
Time frame: 1 and 6 weeks, and 3, 6 and 12 months after treatment
Results and safety
The study was stopped early (reason given: A design change was required following the first treatment. The design concept was not feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuflo BPH Treatment System in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by ProstaCare Pty Ltd at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: A design change was required following the first treatment. The design concept was not feasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Relief of BPH symptoms as measured by International Prostate Symptom Score (IPSS) (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.