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

1. Trial at a Glance

This page covers the registry results for To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. (NCT02962674), a na na study. The primary outcome is Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit.

2. Clinical Question

3. Trial Design

This was a prospective device study listed as single-group, with no masking. Allocation is recorded as NA, and the phase is listed as NA. The intervention entry is the prostaFix System, a device; the title refers to the ProstaCare Water Electrolysis System. The registry describes the purpose as evaluating safety and performance in relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia.

The registry reports enrollment of 49. The study start date is 2016-09-19 and primary completion is recorded as 2018-10-30. Its status is TERMINATED. The reason for termination, the number treated, and the number completing follow-up are not reported in the registry record. The registry sponsor is ProstaCare Singapore Pte. Ltd.

There is no control group listed. Consequently, the design can describe outcomes observed after device treatment, but does not directly compare those outcomes with a concurrent untreated group or another treatment. The lack of masking also means the record does not establish that outcome assessment was blinded.

The primary outcome is mean IPSS at the 3 months follow-up visit, with the stated effectiveness objective framed around improvement from baseline. The registry lists secondary outcomes involving quality of life, peak flow rate, post-void residual, sexual health measures and IPSS. It records 14 outcome measures and 1 analysis, but the detailed analysis plan and the results for the primary and secondary outcomes are not reported in the registry record.

The primary analysis population is labelled intent-to-treat with LOCF, while its definition requires treatment and completion of the 3 month visit without significant protocol deviations. That definition should be kept in view when interpreting the label: the registry does not give enough information to establish who was included in the analysis or how missing observations were handled in practice.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 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.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: All subjects who enrolled in the study and were treated with the prostaFix System.

6. Primary Endpoint

The registry lists the primary outcome as Mean International Prostate Symptom Score (IPSS) at 3 Months Follow-up Visit, measured over 3 months after treatment.

The primary outcome is mean International Prostate Symptom Score (IPSS) at the 3 months follow-up visit. The registry describes IPSS as a validated questionnaire used to assess BPH symptoms before and after treatment. It includes seven questions about urinary symptoms and one question about quality of life. Each urinary-symptom item has six possible answers assigned points from 0 to 5; the total score ranges from 0 to 35. Lower scores correspond to less severe symptoms, and improvement is represented by a decrease in IPSS.

The stated primary effectiveness objective is not simply to report a follow-up score. It is to demonstrate that mean IPSS improvement, denoted as change from baseline in the registry description, exceeded 6.5 points with 95% confidence at 3 months after treatment. The confidence requirement makes the uncertainty around the estimated improvement part of the intended claim, rather than treating the observed mean alone as sufficient.

IPSS is used because it provides a structured measure of urinary symptoms and quality of life in BPH. A mean summarizes the group’s scores, but it does not describe how scores vary among individuals. The registry lists standard error as the dispersion measure for the primary outcome. The observed mean, standard error, confidence interval and test result are not reported in the registry record, so the stated objective cannot be assessed from the information available.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous score, so the registry reports its summary as a mean and its dispersion as a standard error. A mean describes the central level of scores in the analyzed group. It does not show whether scores are tightly clustered or widely spread among individuals. A standard error describes the precision of an estimated mean under the statistical model; it is not the same thing as the spread of individual scores.

In general, a confidence interval combines an estimate with its uncertainty to give a range of values compatible with the data and model. A narrower interval indicates greater precision, while a wider interval indicates less precision. The primary objective specified a 95% confidence requirement for showing that mean IPSS improvement exceeded 6.5 points. To assess that objective, readers would need the estimated improvement and its interval, or an equivalent reported test result. None of those primary result values is reported in the registry record.

The endpoint description defines improvement as a decrease in IPSS. That direction matters when interpreting a change score: a decrease corresponds to improvement according to the registry, while an increase corresponds to worsening on the scale. The objective refers to mean improvement exceeding a threshold, so the point estimate alone would not answer the question; its uncertainty in relation to that threshold is also relevant. No conclusion about that comparison can be drawn without the result.

Because the study is single-group, the primary analysis is not a comparison between randomized treatment arms. A baseline-to-follow-up change can describe what happened among the analyzed participants over time. In general, however, such a change does not isolate the effect of treatment from other influences. Without a concurrent comparator, it is not possible to use this study alone to separate treatment effects from natural history, contextual effects, changes in care, or other time-related factors. These are general design considerations, not findings about this trial.

The registry labels the analysis population intent-to-treat with last observation carried forward. Its stated definition includes people who enrolled, were treated with the prostaFix System, and completed the 3 month follow-up visit without significant protocol deviations. The label and definition do not align in the usual sense of an intent-to-treat population that retains all participants assigned to a group, regardless of treatment received or follow-up completion. Since this is a single-group study and allocation is recorded as NA, the registry does not explain how the label was operationalized.

LOCF is a method for filling in missing follow-up values by carrying forward an earlier observation. As a general matter, this can make an analysis depend on an assumption that the carried-forward value is a reasonable stand-in for the value that would have been observed later. If the outcome changes over time, or if missingness is related to participants’ health or experience, that assumption may not hold. LOCF can therefore affect both the estimated mean and its uncertainty. The registry does not report how many values were carried forward, the reasons for missingness, or whether sensitivity analyses were conducted.

The record identifies standard error as the primary outcome’s dispersion measure, but does not report its value. Without it, readers cannot gauge the precision of the mean from the primary result. The record also does not specify the statistical test, confidence-interval method, treatment of deviations, or any adjustment factors. These analysis details are not reported in the registry record and should not be inferred from the objective wording.

The registry lists 14 outcome measures and 1 analysis. The secondary outcomes include changes in quality of life, peak flow rate, post-void residual, MSHQ-EjD score, IIEF score and IPSS. When a study assesses multiple outcomes, there is a general risk that emphasis on favorable findings may overstate the strength of evidence if outcome selection and multiplicity are not addressed. The registry record does not report a multiplicity strategy or a hierarchy beyond identifying the primary outcome. It also does not report the results needed to assess whether any secondary findings were prespecified, analyzed, or interpreted with adjustment.

The sample-size assumptions describe planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect set as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power. They do not show the probability that this completed study found an effect, and their two-arm assumptions do not describe the listed single-group design. No trial-specific sample-size justification is reported in the registry record.

Over-dispersion is a general concern when a statistical model assumes less variability than the data contain. In such a setting, standard errors can be underestimated and confidence intervals can be too narrow. This issue is particularly relevant for outcomes with event counts or clustered observations, but the registry's primary endpoint is a continuous IPSS mean. The statistical model and any checks for distributional assumptions are not reported in the registry record, so there is no basis for claiming that over-dispersion was assessed or was present.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("prostaFix System")
n   <- c(46)
m   <- c(12.3)
sp  <- c(1.22)
sd  <- sp * sqrt(n)      # standard errors converted to SDs
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  prostaFix System  46  12.300  8.274  9.843  14.757

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures and identifies mean IPSS at the 3 months follow-up visit as the primary outcome. It also lists secondary outcomes concerning quality of life, peak flow rate, post-void residual, MSHQ-EjD score, IIEF score and IPSS. The registry record does not report a statistical plan for controlling multiplicity, a hierarchy for testing outcomes, or which outcomes were intended to support confirmatory conclusions. When multiple outcomes are examined, unadjusted tests can produce more opportunities for apparently notable findings by chance; this is a general statistical concern, not a statement about the results of this study.

The analysis-population description is labelled intent-to-treat with LOCF. In the registry’s definition, it includes participants who enrolled, received treatment and completed the 3 month follow-up without significant protocol deviations. The number included in the primary analysis and the number with missing outcome data are not reported in the registry record. The definition therefore leaves uncertainty about how closely the analysis population followed the intent-to-treat label.

LOCF carries an earlier observation forward when a later one is missing. This method can be sensitive to why observations are missing and whether the outcome would have remained stable. The registry does not report the amount or pattern of missing data, the reasons for missingness, or sensitivity analyses comparing alternative approaches. It also does not report whether participants who stopped follow-up differed from those who completed it.

The statistical handling of protocol deviations, missing values and secondary outcomes is not reported in the registry record. These omissions limit assessment of how robust the primary result would be to different analysis choices. In addition, the primary result itself is not reported, so neither the direction nor the precision of the estimated IPSS change can be evaluated.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: haematuria (2.2%), haemorrhage (secondary) (2.2%), urinary tract infection (2.2%), traumatic brain injury (2.2%).

The registry reports 3 serious adverse events among 46 at risk in the prostaFix System group. It also reports 24 other adverse events among 46 at risk and 0 deaths. These are separate registry categories; the figures should not be added together or interpreted as a count of unique participants, because the record does not state whether people could contribute more than one event or appear in more than one category.

The listed serious adverse event terms are Haematuria, Haemorrhage (secondary), Urinary Tract Infection and Traumatic brain injury. Each is displayed with a percentage of 2.2%. The registry does not provide further event descriptions, timing, severity details beyond the serious classification, or attribution to the device. The percentages should therefore be read as the registry’s reported values, not as evidence that the device caused the events.

These figures do not compare safety with another treatment, since no comparator group is listed. They also do not show the duration of exposure or provide a detailed account of follow-up. The registry status is TERMINATED, but the reason is not reported in the registry record. The available counts are a limited description of reported events and do not by themselves establish the overall safety profile.

13. What the Result Does, and Does Not, Mean

The study was designed to evaluate the safety and performance of the prostaFix System for relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia. Its primary effectiveness objective was to show that mean IPSS improvement exceeded 6.5 points with 95% confidence at 3 months after treatment. The registry record does not report the observed mean change, its standard error, a confidence interval, or a test result. It therefore does not establish whether the primary objective was met.

Even if a baseline-to-follow-up improvement were reported, the single-group design would describe change among the analyzed participants rather than provide a controlled estimate of the treatment effect. Without a comparator, other influences on symptom scores cannot be separated from treatment-related change. This is a general limitation of uncontrolled before-and-after evidence.

The registry-reported safety figures provide counts of serious and other adverse events and a death count. They do not establish whether events were caused by the device, and without a comparator they cannot show how those figures relate to another treatment or to an untreated course. The record does not include detailed event timing, exposure information or reasons for termination.

The primary analysis population is labelled intent-to-treat with LOCF, but its stated definition requires treatment and completion of follow-up without significant protocol deviations. The number included, extent of missing data and sensitivity of results to analysis choices are not reported. These issues make it difficult to judge how representative the planned analysis would be of everyone enrolled.

The information in the registry supports a description of the study design, endpoint, analysis-population definition and listed safety events. It does not support a conclusion about the size or precision of the primary outcome, whether the target was achieved, or comparative effectiveness. Those outcome and analysis results are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial raises several statistical questions that matter when interpreting device studies. The primary objective is expressed as a threshold claim: mean IPSS improvement was intended to exceed 6.5 points with 95% confidence. That framing makes the uncertainty around the estimate central. A mean change alone would not establish the objective; the confidence interval or equivalent inferential result would also be needed. Those primary results are not reported in the registry record.

The single-group design is also important. It can describe outcomes after treatment, but does not provide a concurrent comparison that helps distinguish treatment-associated change from other changes over time. This limitation is particularly relevant for symptom scores collected by questionnaire, where expectations and measurement context may influence responses. The absence of masking is recorded, but the details of outcome administration are not reported.

The analysis-population definition deserves attention because it combines an intent-to-treat label with requirements for treatment and completion of the 3 month visit without significant protocol deviations. That makes it important to know who was included, who was excluded, and how missing outcomes were handled. The record states LOCF but does not report the amount of missing data or sensitivity analyses.

The registry also identifies multiple outcomes, while not reporting how multiplicity was handled. For readers of clinical research, a prespecified outcome hierarchy and transparent reporting of all analyses help distinguish the principal question from exploratory findings. Here, the primary outcome result and secondary outcome results are not reported in the registry record.

The safety figures are useful as a record of reported events, but they have no comparator and lack detailed context. Together, these features illustrate why an endpoint, an analysis population, missing-data handling, and study design must be considered alongside any reported estimate. In this case, the registry record does not include the outcome estimates needed to evaluate the primary objective.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpreting this trial is that the registry record does not report the primary endpoint result. It provides the objective and the intended confidence requirement, but not the observed IPSS mean, its standard error, confidence interval, or test result. As a result, the primary effectiveness objective cannot be evaluated from the registry information.

The study is listed as single-group, with no comparator. Any change from baseline would not, on its own, distinguish treatment-related change from other influences over time. Masking is listed as NONE. The record does not describe outcome-assessment procedures or steps to limit possible measurement or expectation effects.

The primary population is labelled intent-to-treat with LOCF, yet the stated definition requires that participants were treated and completed the 3 month follow-up without significant protocol deviations. The number meeting the definition, the number treated, and the number completing follow-up are not reported. The extent and pattern of missing data and the number of carried-forward observations are also not reported.

The record does not report the statistical test, confidence-interval method, multiplicity approach, sensitivity analyses, or a trial-specific sample-size justification. It lists 14 outcome measures and 1 analysis, but does not provide the outcome results. The sample-size assumptions describe planning illustrations rather than the study's own design.

Safety reporting is limited to event counts, a death count and listed serious-event terms with displayed percentages. Event timing, exposure duration, attribution and detailed clinical context are not reported. The study status is TERMINATED, but the reason for termination is not reported in the registry record. These omissions prevent a fuller assessment of outcome completeness, analysis robustness and safety context.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. — NCT02962674.
• Registry record last updated 2021-10-15; status last verified 2021-10.
• Results first posted 2021-10-15.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT02962674 is a single-group device study of the prostaFix System for benign prostatic hyperplasia, sponsored by ProstaCare Singapore Pte. Ltd. The registry reports enrollment of 49, a start date of 2016-09-19, primary completion on 2018-10-30, and status TERMINATED.

The primary outcome is mean IPSS at the 3 months follow-up visit. The stated objective was to show mean improvement exceeding 6.5 points with 95% confidence. The primary result and the reason for termination are not reported in the registry record. The stated analysis population is labelled intent-to-treat with LOCF and requires treatment and completion of follow-up without significant protocol deviations.

Safety entries report 3 serious adverse events among 46 at risk, 24 other adverse events among 46 at risk, and 0 deaths. No comparator is listed. The registry does not report the detailed outcome estimates needed to assess the primary objective or comparative effects.