Back to resultsTo Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
Primary Purpose
Benign Prostatic Hyperplasia
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
prostaFix System
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring BPH
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.
Sites / Locations
- Urology Bay of Plenty (BOP)
- National University Hospital
- Singapore General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02962674
First Posted
November 9, 2016
Last Updated
October 13, 2021
Sponsor
ProstaCare Singapore Pte. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02962674
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
November 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProstaCare Singapore Pte. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
BPH
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
prostaFix System
Primary Outcome Measure Information:
Title
Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit
Description
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.
Time Frame
3 months after treatment
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
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.
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Mean Change in QOL From Baseline
Description
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.
Time Frame
Baseline and 3 months after treatment
Title
Mean Change in Peak Flow Rate (Qmax) From Baseline
Description
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.
Time Frame
Baseline and 3 months after treatment
Title
Mean Change in Post Void Residual (PVR) From Baseline
Description
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.
Time Frame
Baseline and 3 months after treatment
Title
Mean Change in MSHQ-EjD Score From Baseline
Description
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.
Time Frame
Baseline and 3 months after treatment
Title
Change in IIEF Score From Baseline
Description
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.
Time Frame
Baseline and 3 months after treatment
Title
Mean Change in IPSS From Baseline
Description
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.
Time Frame
Baseline and 12 months from treatment
Title
Mean Change in QOL From Baseline
Description
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.
Time Frame
Baseline and 12 months from treatment
Title
Mean Change in Peak Flow Rate (Qmax) From Baseline
Description
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.
Time Frame
Baseline and 12 months from treatment
Title
Mean Change in Post Void Residual (PVR) From Baseline
Description
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.
Time Frame
Baseline and 12 months from treatment
Title
Mean Change in MSHQ-EjD From Baseline
Description
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.
Time Frame
Baseline and 12 months from treatment
Title
Mean Change in IIEF From Baseline
Description
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.
Time Frame
Baseline and 12 months from treatment
Title
MRI Necrosis Volume
Description
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.
Time Frame
3 months after treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Ho Sun Sien, MD
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Bay of Plenty (BOP)
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
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