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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
Date last updated
24/11/2023

Titles & IDs
Public title
Neuflo System for the Treatment of BPH
Scientific title
Neuflo Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia
Secondary ID [1] 0 0
Neuflo-CIP-ANZ-202303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Lower Urinary Tract Symptoms 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness: Relief of BPH symptoms as measured by International Prostate Symptom Score (IPSS)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
3 months after treatment
Secondary outcome [1] 0 0
Improvement in urinary function (Qmax)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
At 3 months after treatment
Secondary outcome [2] 0 0
Improvement in urinary function (PVR)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
At 3 months after treatment
Secondary outcome [3] 0 0
Improvement in sexual function
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
At 3 months after treatment
Secondary outcome [4] 0 0
Improvement in quality of life
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
At 3 months after treatment
Secondary outcome [5] 0 0
Treatment tolerability & procedural medication requirements
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
On day of treatment only
Secondary outcome [6] 0 0
Secondary intervention and medication use for Lower Urinary Tract Symptoms (LUTS)
Assessment method [6] 0 0
Document use of secondary intervention for treatment of LUTS and medication requirements at follow up visits beyond 6 weeks.
Timepoint [6] 0 0
At 3, 6 and12 months after treatment
Secondary outcome [7] 0 0
Neuflo System performance
Assessment method [7] 0 0
Frequency of system deficiencies including adverse events during treatment.
Timepoint [7] 0 0
On day of treatment only
Secondary outcome [8] 0 0
Neuflo System performance on Larger Prostates
Assessment method [8] 0 0
Comparison of primary outcome on 56cm3 to 80cm3 prostates relative to 25cm3 to 55cm3 prostates
Timepoint [8] 0 0
At 3 months after treatment
Secondary outcome [9] 0 0
Maintenance of improvement of LUTS
Assessment method [9] 0 0
Percent change in IPSS score between baseline and 12 months after treatment.
Timepoint [9] 0 0
At 12 months after treatment
Secondary outcome [10] 0 0
Participant satisfaction
Assessment method [10] 0 0
Participant satisfaction score (satisfied with the procedure) measured on a 5 point scale with higher scores indicating greater satisfaction.
Timepoint [10] 0 0
1 and 6 weeks, and 3, 6 and 12 months after treatment

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
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ProstaCare Pty Ltd
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Flora Yuen
Address 0 0
Country 0 0
Phone 0 0
+61 2 9460 6688
Email 0 0
flora.yeun@avaniaclinical.com
Contact person for scientific queries

Data sharing statement


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