Clinical trial NCT02962674: To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
Official title: ProstaCare Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: BPH
Lead sponsor: ProstaCare Pty Ltd
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 49
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and performance of the ProstaCare System in relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia.


Eligibility criteria: Key Inclusion Criteria:

* 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 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.

Primary outcomes:
measure: Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit
timeFrame: 3 months after treatment
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Mean Change in QOL From Baseline
timeFrame: Baseline and 3 months after treatment
measure: Mean Change in Peak Flow Rate (Qmax) From Baseline
timeFrame: Baseline and 3 months after treatment
measure: Mean Change in Post Void Residual (PVR) From Baseline
timeFrame: Baseline and 3 months after treatment
measure: Mean Change in MSHQ-EjD Score From Baseline
timeFrame: Baseline and 3 months after treatment
measure: Change in IIEF Score From Baseline
timeFrame: Baseline and 3 months after treatment
measure: Mean Change in IPSS From Baseline
timeFrame: Baseline and 12 months from treatment
measure: Mean Change in QOL From Baseline
timeFrame: Baseline and 12 months from treatment
measure: Mean Change in Peak Flow Rate (Qmax) From Baseline
timeFrame: Baseline and 12 months from treatment
measure: Mean Change in Post Void Residual (PVR) From Baseline
timeFrame: Baseline and 12 months from treatment
measure: Mean Change in MSHQ-EjD From Baseline
timeFrame: Baseline and 12 months from treatment
measure: Mean Change in IIEF From Baseline
timeFrame: Baseline and 12 months from treatment
measure: MRI Necrosis Volume
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Tauranga
country: New Zealand
facility: Urology Bay of Plenty (BOP)
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Henry Ho Sun Sien, MD
role: PRINCIPAL_INVESTIGATOR
References: