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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05884580
Registration number
NCT05884580
Ethics application status
Date submitted
23/05/2023
Date registered
1/06/2023
Titles & IDs
Public title
Neuflo System for the Treatment of BPH
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Scientific title
Neuflo Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia
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Secondary ID [1]
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Neuflo-CIP-ANZ-202303
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia
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Lower Urinary Tract Symptoms
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Neuflo BPH Treatment System
Experimental: Participants receiving treatment with the Neuflo BPH Treatment System. -
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Effectiveness: Relief of BPH symptoms as measured by International Prostate Symptom Score (IPSS)
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Assessment method [1]
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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.
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Timepoint [1]
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3 months after treatment
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Secondary outcome [1]
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Improvement in urinary function (Qmax)
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Assessment method [1]
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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.
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Timepoint [1]
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At 3 months after treatment
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Secondary outcome [2]
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Improvement in urinary function (PVR)
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Assessment method [2]
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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.
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Timepoint [2]
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At 3 months after treatment
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Secondary outcome [3]
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Improvement in sexual function
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Assessment method [3]
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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.
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Timepoint [3]
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At 3 months after treatment
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Secondary outcome [4]
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Improvement in quality of life
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Assessment method [4]
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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.
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Timepoint [4]
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At 3 months after treatment
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Secondary outcome [5]
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Treatment tolerability & procedural medication requirements
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Assessment method [5]
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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.
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Timepoint [5]
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On day of treatment only
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Secondary outcome [6]
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Secondary intervention and medication use for Lower Urinary Tract Symptoms (LUTS)
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Assessment method [6]
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Document use of secondary intervention for treatment of LUTS and medication requirements at follow up visits beyond 6 weeks.
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Timepoint [6]
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At 3, 6 and12 months after treatment
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Secondary outcome [7]
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Neuflo System performance
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Assessment method [7]
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Frequency of system deficiencies including adverse events during treatment.
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Timepoint [7]
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On day of treatment only
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Secondary outcome [8]
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Neuflo System performance on Larger Prostates
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Assessment method [8]
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Comparison of primary outcome on 56cm3 to 80cm3 prostates relative to 25cm3 to 55cm3 prostates
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Timepoint [8]
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At 3 months after treatment
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Secondary outcome [9]
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Maintenance of improvement of LUTS
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Assessment method [9]
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Percent change in IPSS score between baseline and 12 months after treatment.
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Timepoint [9]
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At 12 months after treatment
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Secondary outcome [10]
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Participant satisfaction
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Assessment method [10]
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Participant satisfaction score (satisfied with the procedure) measured on a 5 point scale with higher scores indicating greater satisfaction.
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Timepoint [10]
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1 and 6 weeks, and 3, 6 and 12 months after treatment
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Eligibility
Key inclusion criteria
Participants must meet all inclusion criteria to participate in this study.
1. Males aged 45 years of age or older
2. IPSS score of 13 or higher
3. Eligible uroflow with unadjusted or adjusted peak flow rate of equal to or less than 13ml/sec with a corresponding:
1. voided volume of at least 100 ml, and,
2. Post Void Residual (PVR) of 250 ml or less
4. Prostate volume of 25-80 cm3, inclusive as measured by ultrasound or MRI
5. Prostatic sagittal length of 3.2 cm or greater, as measured by ultrasound or MRI
6. Prostatic transverse width of 3.5 cm or greater as measured by ultrasound or MRI
7. Prostatic anterior-posterior height of 2.5 cm or greater as measured by ultrasound or MRI
8. Participant must have the ability to understand and consent to participate in this study
9. Participant must be willing and able to participate in follow-up evaluations
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants meeting any of the exclusion criteria listed at baseline will be excluded from participation.
1. Outlet obstruction due to an enlarged middle lobe or significant central gland of the prostate
2. Significant transverse asymmetry of prostatic lateral lobes
3. Participant has an implantable pacemaker or cardiac defibrillator
4. Participant has a penile implant
5. History or current diagnosis of prostate cancer or bladder cancer
6. Active urinary tract infection (UTI) (Note: participant can be enrolled if the UTI is treated and followed with a negative urine test result)
7. Neurogenic, decompensated, or atonic bladder
8. Overactive bladder in the absence of prostatic obstruction
9. Current, recurrent (two or more) urethral strictures or muscle spasms that prevent insertion of the catheter
10. 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)
11. Previous rectal surgery other than haemorrhoidectomy
12. Previous radical pelvic surgery or pelvic irradiation
13. Interest in maintaining fertility
14. Previous surgery or minimally invasive procedure(s) to treat symptomatic BPH
15. 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)
16. 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)
17. Concomitant bladder stones
18. History of other diseases or conditions causing voiding dysfunction
19. Current medication affecting bladder function
20. Known allergy to nickel
21. Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
22. History of medical, surgical, or other conditions that, in the opinion of the investigator, would limit study participation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/12/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Tauranga
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ProstaCare Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 1 week to assess the volume and location of ablated tissue. The duration of the study is expected to be 18 months.
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Trial website
https://clinicaltrials.gov/study/NCT05884580
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Flora Yuen
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Address
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Country
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Phone
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+61 2 9460 6688
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05884580