To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.

ProstaCare Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia

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.

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: prostaFix System

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Tauranga, New Zealand, 3112
    • Urology Bay of Plenty (BOP)
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment	Device: prostaFix System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit	The primary effectiveness objective was to demonstrate that mean IPSS improvement (Δ 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.	3 months after treatment
Number of Participants With Serious Adverse Events (SAEs)	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.	3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in QOL From Baseline	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.	Baseline and 3 months after treatment
Mean Change in Peak Flow Rate (Qmax) From Baseline	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.	Baseline and 3 months after treatment
Mean Change in Post Void Residual (PVR) From Baseline	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.	Baseline and 3 months after treatment
Mean Change in MSHQ-EjD Score From Baseline	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.	Baseline and 3 months after treatment
Change in IIEF Score From Baseline	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.	Baseline and 3 months after treatment
Mean Change in IPSS From Baseline	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.	Baseline and 12 months from treatment
Mean Change in QOL From Baseline	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.	Baseline and 12 months from treatment
Mean Change in Peak Flow Rate (Qmax) From Baseline	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.	Baseline and 12 months from treatment
Mean Change in Post Void Residual (PVR) From Baseline	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.	Baseline and 12 months from treatment
Mean Change in MSHQ-EjD From Baseline	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.	Baseline and 12 months from treatment
Mean Change in IIEF From Baseline	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.	Baseline and 12 months from treatment
MRI Necrosis Volume	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.	3 months after treatment

Collaborators and Investigators

• Sponsor: ProstaCare Singapore Pte. Ltd.
• Investigators: Principal Investigator: Henry Ho Sun Sien, MD, Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: BPH
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CIP# PC 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No