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. 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.
∙ 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
• 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