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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
Timepoint [1] 0 0
3 months after treatment
Primary outcome [2] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
3 months after treatment
Secondary outcome [1] 0 0
Mean Change in QOL From Baseline
Timepoint [1] 0 0
Baseline and 3 months after treatment
Secondary outcome [2] 0 0
Mean Change in Peak Flow Rate (Qmax) From Baseline
Timepoint [2] 0 0
Baseline and 3 months after treatment
Secondary outcome [3] 0 0
Mean Change in Post Void Residual (PVR) From Baseline
Timepoint [3] 0 0
Baseline and 3 months after treatment
Secondary outcome [4] 0 0
Mean Change in MSHQ-EjD Score From Baseline
Timepoint [4] 0 0
Baseline and 3 months after treatment
Secondary outcome [5] 0 0
Change in IIEF Score From Baseline
Timepoint [5] 0 0
Baseline and 3 months after treatment
Secondary outcome [6] 0 0
Mean Change in IPSS From Baseline
Timepoint [6] 0 0
Baseline and 12 months from treatment
Secondary outcome [7] 0 0
Mean Change in QOL From Baseline
Timepoint [7] 0 0
Baseline and 12 months from treatment
Secondary outcome [8] 0 0
Mean Change in Peak Flow Rate (Qmax) From Baseline
Timepoint [8] 0 0
Baseline and 12 months from treatment
Secondary outcome [9] 0 0
Mean Change in Post Void Residual (PVR) From Baseline
Timepoint [9] 0 0
Baseline and 12 months from treatment
Secondary outcome [10] 0 0
Mean Change in MSHQ-EjD From Baseline
Timepoint [10] 0 0
Baseline and 12 months from treatment
Secondary outcome [11] 0 0
Mean Change in IIEF From Baseline
Timepoint [11] 0 0
Baseline and 12 months from treatment
Secondary outcome [12] 0 0
MRI Necrosis Volume
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.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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