Trial Outcomes & Findings for To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. (NCT NCT02962674)

NCT ID: NCT02962674

Last Updated: 2021-10-15

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: 3 months after treatment
• Results posted on: 2021-10-15

Participant Flow

Participant milestones

Measure	prostaFix System Subjects treated with the prostaFix Water Electrolysis System
Overall Study STARTED	49
Overall Study 3 Month Endpoint	46
Overall Study 12 Month Durability	46
Overall Study 24 Month Durability	32
Overall Study 36 Month Durability	18
Overall Study 48 Month Durability	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	49

Reasons for withdrawal

Measure	prostaFix System Subjects treated with the prostaFix Water Electrolysis System
Overall Study Study terminated by sponsor prior to completion of all study protocol visits by enrolled subjects.	49

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment n=46 Participants Subjects treated with the prostaFix System
Age, Continuous	66.9 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Race/Ethnicity, Customized Race · Chinese	28 Participants n=5 Participants
Race/Ethnicity, Customized Race · Malay	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Indian	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · New Zealand European	14 Participants n=5 Participants
Region of Enrollment New Zealand	14 Participants n=5 Participants
Region of Enrollment Singapore	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit	12.3 score on a scale Standard Error 1.22

PRIMARY outcome

Timeframe: 3 months after treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Number of Participants With Serious Adverse Events (SAEs)	0 Participants

SECONDARY outcome

Timeframe: Baseline and 3 months after treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in QOL From Baseline	-2.2 score on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: Baseline and 3 months after treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in Peak Flow Rate (Qmax) From Baseline	2.36 ml/sec Standard Error 0.64

SECONDARY outcome

Timeframe: Baseline and 3 months after treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in Post Void Residual (PVR) From Baseline	-3.54 ml Standard Error 9.46

SECONDARY outcome

Timeframe: Baseline and 3 months after treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in MSHQ-EjD Score From Baseline MSHQ-EjD (Total)	0.6 score on a scale Standard Error 0.48
Mean Change in MSHQ-EjD Score From Baseline MSHQ-EjD (Bother)	-0.4 score on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: Baseline and 3 months after treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=30 Participants Subjects treated with the prostaFix Water Electrolysis System
Change in IIEF Score From Baseline	-0.5 score on a scale Standard Error 1.12

SECONDARY outcome

Timeframe: Baseline and 12 months from treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in IPSS From Baseline	-8.6 score on a scale Standard Error 1.06

SECONDARY outcome

Timeframe: Baseline and 12 months from treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in QOL From Baseline	-1.3 score on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline and 12 months from treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in Peak Flow Rate (Qmax) From Baseline	0.99 ml/sec Standard Error 0.49

SECONDARY outcome

Timeframe: Baseline and 12 months from treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in Post Void Residual (PVR) From Baseline	-1.82 ml Standard Error 9.64

SECONDARY outcome

Timeframe: Baseline and 12 months from treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=46 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in MSHQ-EjD From Baseline MSHQ-EjD (Total)	-0.6 score on a scale Standard Error 0.5
Mean Change in MSHQ-EjD From Baseline MSHQ-EjD (Bother)	-0.2 score on a scale Standard Error 0.34

SECONDARY outcome

Timeframe: Baseline and 12 months from treatment

Population: Intent-to-treat (ITT) with last observation carried forward (LOCF): All subjects who enrolled in the study, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations.

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.

Outcome measures

Measure	prostaFix System n=30 Participants Subjects treated with the prostaFix Water Electrolysis System
Mean Change in IIEF From Baseline	-1.9 score on a scale Standard Error 1.23

SECONDARY outcome

Timeframe: 3 months after treatment

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.

Outcome measures

Measure	prostaFix System n=14 Participants Subjects treated with the prostaFix Water Electrolysis System
MRI Necrosis Volume	0.12 cm^3 Standard Deviation 0.25

Adverse Events

prostaFix System

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	prostaFix System n=46 participants at risk Subjects treated with the prostaFix Water Electrolysis System
Renal and urinary disorders Haematuria	2.2% 1/46 • Number of events 1 • Adverse events were collected from enrollment until study termination. All enrolled subjects were followed to at least their 12-month follow-up visit. AEs were classified by the investigator at each corresponding site for relatedness to the device and seriousness based on the Common Terminology Criteria for Adverse Events (Version 4.03) (CTCAE) (US Department of Health and Human Services 2010) guidelines. In addition, the adverse events were coded using MedDRA and reviewed by the Medical Advisor.
Surgical and medical procedures Haemorrhage (secondary)	2.2% 1/46 • Number of events 1 • Adverse events were collected from enrollment until study termination. All enrolled subjects were followed to at least their 12-month follow-up visit. AEs were classified by the investigator at each corresponding site for relatedness to the device and seriousness based on the Common Terminology Criteria for Adverse Events (Version 4.03) (CTCAE) (US Department of Health and Human Services 2010) guidelines. In addition, the adverse events were coded using MedDRA and reviewed by the Medical Advisor.
Renal and urinary disorders Urinary Tract Infection	2.2% 1/46 • Number of events 1 • Adverse events were collected from enrollment until study termination. All enrolled subjects were followed to at least their 12-month follow-up visit. AEs were classified by the investigator at each corresponding site for relatedness to the device and seriousness based on the Common Terminology Criteria for Adverse Events (Version 4.03) (CTCAE) (US Department of Health and Human Services 2010) guidelines. In addition, the adverse events were coded using MedDRA and reviewed by the Medical Advisor.
Injury, poisoning and procedural complications Traumatic brain injury	2.2% 1/46 • Number of events 1 • Adverse events were collected from enrollment until study termination. All enrolled subjects were followed to at least their 12-month follow-up visit. AEs were classified by the investigator at each corresponding site for relatedness to the device and seriousness based on the Common Terminology Criteria for Adverse Events (Version 4.03) (CTCAE) (US Department of Health and Human Services 2010) guidelines. In addition, the adverse events were coded using MedDRA and reviewed by the Medical Advisor.

Other adverse events

Measure	prostaFix System n=46 participants at risk Subjects treated with the prostaFix Water Electrolysis System
Musculoskeletal and connective tissue disorders Back Pain	8.7% 4/46 • Number of events 4 • Adverse events were collected from enrollment until study termination. All enrolled subjects were followed to at least their 12-month follow-up visit. AEs were classified by the investigator at each corresponding site for relatedness to the device and seriousness based on the Common Terminology Criteria for Adverse Events (Version 4.03) (CTCAE) (US Department of Health and Human Services 2010) guidelines. In addition, the adverse events were coded using MedDRA and reviewed by the Medical Advisor.
Renal and urinary disorders Hypertonic bladder	13.0% 6/46 • Number of events 6 • Adverse events were collected from enrollment until study termination. All enrolled subjects were followed to at least their 12-month follow-up visit. AEs were classified by the investigator at each corresponding site for relatedness to the device and seriousness based on the Common Terminology Criteria for Adverse Events (Version 4.03) (CTCAE) (US Department of Health and Human Services 2010) guidelines. In addition, the adverse events were coded using MedDRA and reviewed by the Medical Advisor.
Renal and urinary disorders Lower urinary tract symptoms (worsened)	28.3% 13/46 • Number of events 13 • Adverse events were collected from enrollment until study termination. All enrolled subjects were followed to at least their 12-month follow-up visit. AEs were classified by the investigator at each corresponding site for relatedness to the device and seriousness based on the Common Terminology Criteria for Adverse Events (Version 4.03) (CTCAE) (US Department of Health and Human Services 2010) guidelines. In addition, the adverse events were coded using MedDRA and reviewed by the Medical Advisor.
Renal and urinary disorders Urinary retention	6.5% 3/46 • Number of events 3 • Adverse events were collected from enrollment until study termination. All enrolled subjects were followed to at least their 12-month follow-up visit. AEs were classified by the investigator at each corresponding site for relatedness to the device and seriousness based on the Common Terminology Criteria for Adverse Events (Version 4.03) (CTCAE) (US Department of Health and Human Services 2010) guidelines. In addition, the adverse events were coded using MedDRA and reviewed by the Medical Advisor.
Renal and urinary disorders Urinary urgency	6.5% 3/46 • Number of events 3 • Adverse events were collected from enrollment until study termination. All enrolled subjects were followed to at least their 12-month follow-up visit. AEs were classified by the investigator at each corresponding site for relatedness to the device and seriousness based on the Common Terminology Criteria for Adverse Events (Version 4.03) (CTCAE) (US Department of Health and Human Services 2010) guidelines. In addition, the adverse events were coded using MedDRA and reviewed by the Medical Advisor.

Additional Information

Annegret Genger

seleon gmbh

Phone: +49 175 934 91 83

Email: Annegret.Genger@seleon.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER