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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02962674




Registration number
NCT02962674
Ethics application status
Date submitted
9/11/2016
Date registered
11/11/2016

Titles & IDs
Public title
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
Scientific title
ProstaCare Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia
Secondary ID [1] 0 0
CIP# PC 1.0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other: Treatment -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit
Assessment method [1] 0 0
The primary effectiveness objective was to demonstrate that mean IPSS improvement (? IPSS) following treatment with the prostaFix System exceeded 6.5 points with 95% confidence 3 months after treatment. The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess baseline and post treatment BPH symptoms. It is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the subject to choose one out of six answers indicating increasing severity of that particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic): Mild (symptom score less than or equal to 7), Moderate (symptom score range 8-19) and Severe (symptom score range 20-35). Improvement in BPH symptoms is seen as a decrease in IPSS.
Timepoint [1] 0 0
3 months after treatment
Primary outcome [2] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Assessment method [2] 0 0
The primary safety objective of this study was to estimate the proportion of subjects affected by serious adverse events (SAEs) associated with the use of the device. This objective was addressed through recording all adverse events (AEs) observed or reported during the course of the study.
Timepoint [2] 0 0
3 months after treatment
Secondary outcome [1] 0 0
Mean Change in QOL From Baseline
Assessment method [1] 0 0
Question eight of the IPSS questionnaire refers to the subject's perceived quality of life (QOL). The International Scientific Committee (SCI), under the patronage of the World Health Organization (WHO) and the International Union Against Cancer (UICC), recommends the use of only a single question to assess the quality of life. The answers to this question range from "delighted" to "terrible" or 0 to 6.
Timepoint [1] 0 0
Baseline and 3 months after treatment
Secondary outcome [2] 0 0
Mean Change in Peak Flow Rate (Qmax) From Baseline
Assessment method [2] 0 0
Uroflowmetry measures the flow of urine. It tracks how fast urine flows (peak flow rate - Qmax), how much flows out, and how long it takes. It's a diagnostic test to assess how well the urinary tract functions. Uroflowmetry is used in BPH subjects to help the doctors determine how well the subject's urinary tract is doing and the severity of obstruction caused by the prostate. The higher the Qmax is, the less obstructed the urethra.
Timepoint [2] 0 0
Baseline and 3 months after treatment
Secondary outcome [3] 0 0
Mean Change in Post Void Residual (PVR) From Baseline
Assessment method [3] 0 0
The Post Void Residual (PVR) is an indicator of urine remaining in the bladder after voiding. A healthy bladder should be fairly empty following urination. A volume \< 50 mL is normal; \< 100 mL is usually acceptable in patients \> 65 years old. The higher the PVR, the more urine is left in the bladder and this can be seen as a sign of increased obstruction of the urethra.
Timepoint [3] 0 0
Baseline and 3 months after treatment
Secondary outcome [4] 0 0
Mean Change in MSHQ-EjD Score From Baseline
Assessment method [4] 0 0
The MSHQ-EjD Short Form (Male Sexual Health Questionnaire - Ejaculatory Disfunction) is composed of three questions that rate ejaculatory function in men. A fourth question measures the MSHQ-EjD Bother, this asks the subject if he is bothered by his level of ejaculatory function. MSHQ-EjD total score ranges from 1 to 15 with a higher score indicating better sexual functioning. MSHQ-EjD bother score ranges from 0 to 5 with a higher score indicating greater bother. An increase in the MSHQ-EjD Total Score indicates better ejaculation and a decrease in the MSHQ-EjD Bother Score means that the subject is less bothered by his ejaculatory function. Due to the sensitive nature of the questions, this questionnaire is voluntary and not all subjects completed it at baseline. Some subjects completed at baseline but decided not to complete at certain follow-up visits which explains the different number of participants during various analysis time frames.
Timepoint [4] 0 0
Baseline and 3 months after treatment
Secondary outcome [5] 0 0
Change in IIEF Score From Baseline
Assessment method [5] 0 0
The IIEF (International Index of Erectile Function) provides a broad measure of sexual function; an increase in score indicates an improvement in sexual function. This questionnaire consists of five questions that asks the subject of any erection problems that have impacted his sexual life over the past 4 weeks or since the last study visit, whichever is shorter. IIEF total score ranges from 0 to 25 with a higher score indicating better sexual functioning and an increase in score indicates an improvement in sexual function. Due to the sensitive nature of the questions, this questionnaire is voluntary and not all subjects completed it at baseline. Some subjects completed at baseline but decided not to complete at certain follow-up visits which explains the different number of participants during various analysis time frames.
Timepoint [5] 0 0
Baseline and 3 months after treatment
Secondary outcome [6] 0 0
Mean Change in IPSS From Baseline
Assessment method [6] 0 0
The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess baseline and post treatment BPH symptoms. It is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the subject to choose one out of six answers indicating increasing severity of that particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic): Mild (symptom score less than or equal to 7), Moderate (symptom score range 8-19) and Severe (symptom score range 20-35). Improvement in BPH symptoms is seen as a decrease in IPSS.
Timepoint [6] 0 0
Baseline and 12 months from treatment
Secondary outcome [7] 0 0
Mean Change in QOL From Baseline
Assessment method [7] 0 0
Question eight of the IPSS questionnaire refers to the subject's perceived quality of life (QOL). The International Scientific Committee (SCI), under the patronage of the World Health Organization (WHO) and the International Union Against Cancer (UICC), recommends the use of only a single question to assess the quality of life. The answers to this question range from "delighted" to "terrible" or 0 to 6.
Timepoint [7] 0 0
Baseline and 12 months from treatment
Secondary outcome [8] 0 0
Mean Change in Peak Flow Rate (Qmax) From Baseline
Assessment method [8] 0 0
Uroflowmetry measures the flow of urine. It tracks how fast urine flows (peak flow rate - Qmax), how much flows out, and how long it takes. It's a diagnostic test to assess how well the urinary tract functions. Uroflowmetry is used in BPH subjects to help the doctors determine how well the subject's urinary tract is doing and the severity of obstruction caused by the prostate. The higher the Qmax is, the less obstructed the urethra.
Timepoint [8] 0 0
Baseline and 12 months from treatment
Secondary outcome [9] 0 0
Mean Change in Post Void Residual (PVR) From Baseline
Assessment method [9] 0 0
The Post Void Residual (PVR) is an indicator of urine remaining in the bladder after voiding. A healthy bladder should be fairly empty following urination. A volume \< 50 mL is normal; \< 100 mL is usually acceptable in patients \> 65 years old. The higher the PVR, the more urine is left in the bladder and this can be seen as a sign of increased obstruction of the urethra.
Timepoint [9] 0 0
Baseline and 12 months from treatment
Secondary outcome [10] 0 0
Mean Change in MSHQ-EjD From Baseline
Assessment method [10] 0 0
The MSHQ-EjD Short Form (Male Sexual Health Questionnaire - Ejaculatory Disfunction) is composed of three questions that rate ejaculatory function in men. A fourth question measures the MSHQ-EjD Bother, this asks the subject if he is bothered by his level of ejaculatory function. MSHQ-EjD total score ranges from 1 to 15 with a higher score indicating better sexual functioning. MSHQ-EjD bother score ranges from 0 to 5 with a higher score indicating greater bother. An increase in the MSHQ-EjD Total Score indicates better ejaculation and a decrease in the MSHQ-EjD Bother Score means that the subject is less bothered by his ejaculatory function. Due to the sensitive nature of the questions, this questionnaire is voluntary and not all subjects completed it at baseline. Some subjects completed at baseline but decided not to complete at certain follow-up visits which explains the different number of participants during various analysis time frames.
Timepoint [10] 0 0
Baseline and 12 months from treatment
Secondary outcome [11] 0 0
Mean Change in IIEF From Baseline
Assessment method [11] 0 0
The IIEF (International Index of Erectile Function) provides a broad measure of sexual function; an increase in score indicates an improvement in sexual function. This questionnaire consists of five questions that asks the subject of any erection problems that have impacted his sexual life over the past 4 weeks or since the last study visit, whichever is shorter. IIEF total score ranges from 0 to 25 with a higher score indicating better sexual functioning and an increase in score indicates an improvement in sexual function. Due to the sensitive nature of the questions, this questionnaire is voluntary and not all subjects completed it at baseline. Some subjects completed at baseline but decided not to complete at certain follow-up visits which explains the different number of participants during various analysis time frames.
Timepoint [11] 0 0
Baseline and 12 months from treatment
Secondary outcome [12] 0 0
MRI Necrosis Volume
Assessment method [12] 0 0
The prostaFix System uses pH shifts induced by water electrolysis to induce necrosis in the hyperplastic prostate tissue. The induced necrosis within the borders of the prostate result in a pressure reduction and thereby relieve the symptoms of BPH. This necrosis that resulted from the procedure eventually heals and necrosis volume should reduce overtime. Per protocol, only the first 10-15 subjects would have MRI studies at done to assess subject safety and treatment effect. then MRI was optional. A total of 14 subjects actually had an MRI and the results are reported for those subjects.
Timepoint [12] 0 0
3 months after treatment

Eligibility
Key inclusion criteria
Key

* 45 years of age or older with a diagnosis of BPH,
* International Prostate Symptom Score (IPSS) of 12 or greater,
* Prostate volume between 25 cm3 and 55 cm3,
* Uroflow with peak flow rate (Qmax) no greater than 13 ml/sec with a corresponding voided volume of at least 100 ml and a post void residual (PVR) of 250 ml or less.
* Prostate length, width and height must be at least 3.2 cm, 3.5 cm and 2.5 cm, respectively

Key
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Obstruction due to an enlarged middle lobe, central gland or significant transverse asymmetry,
* Subjects on 5 alpha reductase inhibitors (5-ARI) (inclusion only if washed out prior to treatment),
* Subjects on alpha blockers (inclusion only if washed-out before treatment),
* Active urinary tract infection at time of treatment,
* Interest in maintaining fertility,
* Past history of urologic surgery or minimally invasive treatment for BPH,
* History of or current medical conditions contraindicating elective urological procedures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/11/2020
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Tauranga
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ProstaCare Singapore Pte. Ltd.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Henry Ho Sun Sien, MD
Address 0 0
Singapore General Hospital
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02962674