None listed
Conditions
Brief summary
The goal of this study is to assess the safety and performance of the ProstaCath System for the treatment of lower urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH) The ProstaCath System is a minimally invasive prostate therapy device with the intention to administer direct current energy to the body for use by healthcare professionals (urologist). Participants will be enrolled in the study over a 6 month period. Each participant will be treated with the ProstaCath System and assessed at 1 and 6 weeks, and 3, 6, and 12 months post treatment to assess symptoms, urine flow, sexual function and adverse events. A subgroup of participants 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.
Interventions
The ProstaCath System is designed to treat patients with urinary symptoms associated with Benign Prostatic Hyperplasia (BPH). It is an outpatient-based, minimally invasive treatment option and is designed to reduce prostatic tissue in the lateral lobes of the prostate. The reduction of the tissue lowers the increased pressure on the urethral passage through the prostate. The system uses the process of electrolysis to alleviate symptoms of BPH. The electrolysis is performed using 4 electrodes whi
The ProstaCath System is designed to treat patients with urinary symptoms associated with Benign Prostatic Hyperplasia (BPH). It is an outpatient-based, minimally invasive treatment option and is designed to reduce prostatic tissue in the lateral lobes of the prostate. The reduction of the tissue lowers the increased pressure on the urethral passage through the prostate. The system uses the process of electrolysis to alleviate symptoms of BPH. The electrolysis is performed using 4 electrodes which pierce into the tissues of the prostate and a predetermined amount of charge is administered. The procedure will be performed in a clinic by a trained urologist. The urologist will insert the ProstaCath Catheter into the urethra of the patient in order to reach the prostate. The system will deliver a constant direct current for 25 to 30 minutes, until a pre-defined energy dosage (coulombs) is achieved. The patient is only required to have a single treatment. The electrotherapy is delivered as a constant (unmodulated) direct current - no pulsing, frequency, or amplitude modulation is applied. The 4 electrodes operate as two anode–cathode pairs energised simultaneously but independently. Current amplitude per pair is 25 mA, delivered continuously for 25 to 30 minutes until a pre-defined total energy dose of 36 Coulombs is reached, as tracked by the device's coulomb-counting circuit. As this is a single, one-off treatment with no ongoing dosing schedule, adherence monitoring in is not applicable to this study. Investigators in the study will undertake theory-based training a few weeks prior to first patient treatment. Closer to the treatment date (within 1 week), investigators will be given ~2 hours of hands-on training by ProstaCare's Chief Medical Officer.
Sponsors
ProstaCare Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
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. Diagnosis of BPH in their medical records 4. Eligible uroflow with unadjusted or adjusted peak flow rate of equal to or less than 13 ml/sec with a corresponding: voided volume of at least 100 ml, and, PVR of 250 ml or less 5. Prostate volume of 25-60 cm3, inclusive as measured by ultrasound or MRI 6. Prostatic sagittal length of 3.2 cm or greater, as measured by ultrasound or MRI 7. Prostatic transverse width of 3.5 cm or greater as measured by ultrasound or MRI 8. Prostatic anterior-posterior height of 2.5 cm or greater as measured by ultrasound or MRI 9. Participant must have the ability to understand and consent to participate in this study 10. Participant must be willing and able to participate in follow-up evaluations
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 urinary implants like a penile implant or artificial sphincter 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 on anticoagulation medications unless anti-_x0002_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 medication for the treatment of BPH within 28 days prior to treatment day unless the patient has been on a stable dose of the medication for 28 days and will continue the medication unchanged throughout the course of the study (Participants are allowed to delay or repeat screening to fulfil this requirement) 16. Use of 5-ARI medication (5-alpha-reductase inhibitors, an enzyme inhibitor) for the treatment of BPH within 6 months prior to treatment day unless the patient has been on a stable dose of the medication for >6 months and will continue the medication 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
Outcome results
None listed