Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
Keywords
prostate, catheter, IPSS
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.
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.
Interventions
DEVICENeuflo 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.
Sponsors
ProstaCare Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicentre, single-arm clinical evaluation
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
Participants meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Relief of BPH symptoms as measured by International Prostate Symptom Score (IPSS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in urinary function (Qmax) | At 3 months after treatment | 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. |
| Improvement in urinary function (PVR) | At 3 months after treatment | 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. |
| Improvement in sexual function | At 3 months after treatment | 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. |
| Improvement in quality of life | At 3 months after treatment | 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. |
| Treatment tolerability & procedural medication requirements | On day of treatment only | 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. |
| 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. |
| Neuflo System performance on Larger Prostates | At 3 months after treatment | Comparison of primary outcome on 56cm3 to 80cm3 prostates relative to 25cm3 to 55cm3 prostates |
| Participant satisfaction | 1 and 6 weeks, and 3, 6 and 12 months after treatment | Participant satisfaction score (satisfied with the procedure) measured on a 5 point scale with higher scores indicating greater satisfaction. |
| Maintenance of improvement of LUTS | At 12 months after treatment | Percent change in IPSS score between baseline and 12 months after treatment. |
Countries
New Zealand
Outcome results
None listed