Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001092381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
17/08/2026
Date registered
Help: Date registered
4/09/2026
Date last updated
Help: Date last updated
4/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
An Evaluation of the Safety and Performance of the ProstaCath System for Relieving Urinary Symptoms Secondary to Benign Prostatic Hyperplasia (BPH)
Scientific title
An Evaluation of the Safety and Performance of the ProstaCath System for Relieving Urinary Symptoms Secondary to Benign Prostatic Hyperplasia (BPH) in Male Participants 45 Years and Over,
Additional trial identifiers [1] 316215 0
PC-PILOT-CIP-26-ANZSG
Universal Trial Number (UTN)
Trial acronym
ProstaCath Study
Related trial records

Health condition
Health condition(s) studied:
Benign Prostate Hyperplasia (BPH) 340226 0
Condition category
Condition code
Renal and Urogenital 336424 336424 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 332850 0
Treatment: Devices
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343941 0
To investigate the safety of the ProstaCath System.
Timepoint [1] 343941 0
3 Months after treatment
Secondary outcome [1] 456161 0
To investigate the effectiveness of the ProstaCath System for BPH symptoms as measured by the International Prostate Symptom Score (IPSS).
Timepoint [1] 456161 0
Baseline to 3 months after treatment
Secondary outcome [2] 456163 0
To investigate the effectiveness of the ProstaCath System on other urinary symptoms as measured by the IPSS and Quality of Life (QoL) Index
Timepoint [2] 456163 0
Baseline, 1 week, 6 weeks, 3 months, 6 months and 12 months after treatment.
Secondary outcome [3] 456164 0
To characterise changes in erectile function
Timepoint [3] 456164 0
Baseline, 6 weeks, 3 months, 6 months and 12 months after treatment
Secondary outcome [4] 456165 0
To characterise treatment tolerability
Timepoint [4] 456165 0
Day of treatment for tolerability including the following timepoints: 1. After topical anaesthesia 2. After device placement in the urethra 3. After electrode deployment into the prostate 4. At 5 minute intervals throughout therapy (presented as an average) 5. When current delivery is complete 6. When the device is removed from the urethra 7. Prior to leaving the clinic
Secondary outcome [5] 456166 0
To characterise device performance
Timepoint [5] 456166 0
Day of treatment for fluoroscopy and technical observations; at 1 week for MRI.
Secondary outcome [6] 466170 0
To characterise participants satisfaction with the procedure
Timepoint [6] 466170 0
At 1 week, 6 weeks, 3 months, 6 months and 12 months after treatment
Secondary outcome [7] 466889 0
To investigate the effectiveness of the ProstaCath System on Peak Flow Rate (Qmax)
Timepoint [7] 466889 0
At 1 week, 6 weeks, 3 months, 6 months and 12 months after treatment
Secondary outcome [8] 466890 0
To investigate the effectiveness of the ProstaCath System on Post Void Residual (PVR)
Timepoint [8] 466890 0
At 1 week, 6 weeks, 3 months, 6 months and 12 months after treatment
Secondary outcome [9] 466891 0
Exploratory To characterise changes in sexual function
Timepoint [9] 466891 0
At 6 weeks, 3 months, 6 months and 12 months after treatment
Secondary outcome [10] 466892 0
To characterise changes in Quality of Life (QoL) score
Timepoint [10] 466892 0
Baseline, 1 week, 6 weeks, 3 months, 6 months and 12 months after treatment.
Secondary outcome [11] 466893 0
To characterise time to return to normal activity
Timepoint [11] 466893 0
Measured at 1 week after treatment.
Secondary outcome [12] 466895 0
Characterise medication requirements.
Timepoint [12] 466895 0
Day of treatment, 1 week, 6 weeks, 3 months, 6 months 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. 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
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Healthy volunteers
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 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-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



Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/09/2026
Actual
Date of last participant enrolment
Anticipated
31/03/2027
Actual
Date of last data collection
Anticipated
31/10/2028
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29000 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 45276 0
2148 - Blacktown
Recruitment outside Australia
Country [1] 27717 0
Singapore
State/province [1] 27717 0
Country [2] 28430 0
New Zealand
State/province [2] 28430 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 320814 0
Commercial sector/Industry
Name [1] 320814 0
ProstaCare Pty Ltd
Country [1] 320814 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ProstaCare Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 323480 0
None
Name [1] 323480 0
Address [1] 323480 0
Country [1] 323480 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319345 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 319345 0
Ethics committee country [1] 319345 0
Australia
Date submitted for ethics approval [1] 319345 0
29/07/2026
Approval date [1] 319345 0
Ethics approval number [1] 319345 0
Ethics committee name [2] 319630 0
NHG Health Domain Specific Review Boards (DSRB)
Ethics committee address [2] 319630 0
Ethics committee country [2] 319630 0
Singapore
Date submitted for ethics approval [2] 319630 0
16/03/2026
Approval date [2] 319630 0
03/08/2026
Ethics approval number [2] 319630 0
Ethics committee name [3] 321202 0
Central Health and Disability Ethics Committee
Ethics committee address [3] 321202 0
Ethics committee country [3] 321202 0
New Zealand
Date submitted for ethics approval [3] 321202 0
01/07/2026
Approval date [3] 321202 0
Ethics approval number [3] 321202 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 147046 0
Prof Henry Woo
Address 147046 0
Blacktown Hospital, 18 Blacktown Road, Blacktown, NSW, 2148
Country 147046 0
Australia
Phone 147046 0
+61 02 94738765
Fax 147046 0
Email 147046 0
[email protected]
Contact person for public queries
Name 147047 0
Liam Thompson
Address 147047 0
ProstaCare Pty Ltd, Level 5, 56 Pitt Street, Sydney NSW 2000
Country 147047 0
Australia
Phone 147047 0
+61 438459370
Fax 147047 0
Email 147047 0
[email protected]
Contact person for scientific queries
Name 147048 0
Henry Woo
Address 147048 0
Blacktown Hospital, 18 Blacktown Road, Blacktown, NSW, 2148
Country 147048 0
Australia
Phone 147048 0
+61 02 94738765
Fax 147048 0
Email 147048 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.