Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2023-12-31
2024-12-31
Brief Summary
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* 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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants receiving treatment with the Neuflo BPH Treatment System.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
45 Years
MALE
No
Sponsors
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ProstaCare Pty Ltd
INDUSTRY
Responsible Party
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Locations
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Urology Bay of Plenty
Tauranga, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Neuflo-CIP-ANZ-202303
Identifier Type: -
Identifier Source: org_study_id