e۰Sense® Catheter Clinical Investigation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for e۰Sense® Catheter Clinical Investigation (NCT04438499), a na na study. The primary outcome is Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient).

2. Clinical Question

3. Trial Design

This was a completed, single-group clinical investigation of an investigational urodynamic catheter. The registry lists the study as having no phase, no allocation, and no masking. It records enrollment of 61 participants and identifies Laborie Medical Technologies Inc. as the sponsor. The listed study dates are 2020-06-16 for the start and 2020-12-17 for primary completion.

Participants were described as medically indicated for a urodynamics study. The study description states that consenting patients undergoing a medically prescribed invasive, conventional urodynamics test would use the investigational device. The listed intervention is the eSense 7fr Single Sensor Bladder Catheter. The arm description says the eSense catheter was used in all subjects and that there was no comparative, placebo, sham, or control arm.

The primary objective was to gather clinical data intended to confirm safety and effectiveness for urodynamic use. The primary outcome was a clinician safety and effectiveness rating for each subject, recorded on a case report form. The registry gives an approximate 60 minutes timeframe for this outcome. It also lists a secondary outcome concerning the percentage of participants free from severe complication for the updated e۰Sense catheters.

These design details identify the intended study question, but they do not establish what was observed. The registry record does not report the primary outcome result, the secondary outcome result, or analyses for the outcomes. It lists six outcome measures and zero analyses. Without an outcome result, the record cannot establish how clinicians rated the catheters in the enrolled group. The single-group design also means there is no concurrent control group for estimating a comparative treatment effect.

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: Sensitivity analysis "Intent to treat" population.

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 eligible subjects medically indicated for a urodynamics (UDS) study are included in the baseline analysis population.

6. Primary Endpoint

The registry lists the primary outcome as Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient), measured over approximately 60 minutes.

The primary endpoint is the clinician’s binary safety and effectiveness rating of the eSense catheters for each participant. Clinicians were to record on a case report form whether the e۰Sense® bladder and abdominal catheters were safe and effective for urodynamic use. The endpoint is expressed as a count of participants, and the registry identifies the population as an intent-to-treat population for a sensitivity analysis. The assessment timeframe is approximately 60 minutes.

The registry explains that no single or combined objective measure generated from the urodynamics test was considered able to establish device safety and effectiveness for the intended use. It therefore describes clinician feedback as the basis for the binary assessment. In general, a binary endpoint reduces a judgment to one of two recorded categories, which can make the outcome straightforward to interpret. It also means that the endpoint does not, by itself, describe the degree of safety or effectiveness, the reasons behind a rating, or the clinician’s level of certainty.

The outcome description gives the planned measure, not its observed value. The registry record does not report how many participants received each rating, the number included in the analysis, or any estimate of uncertainty for the result. It is therefore not possible to characterize the observed primary endpoint from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What the endpoint represents. The primary outcome is a binary clinician rating for each participant: clinicians were to indicate whether the e۰Sense® bladder and abdominal catheters were safe and effective for urodynamic use. The registry lists the outcome measure as a count of participants and gives an approximate 60 minutes timeframe. In general, binary outcomes classify each observation into one of two categories. The resulting count can be described as a number of participants in each category, and a proportion can be calculated when the relevant denominator is known. The registry record does not report the primary endpoint counts or the denominator used in its analysis, so no such result can be described.

What a single-group design can establish. All subjects were to use the investigational eSense catheter, and the arm description explicitly says there was no comparative, placebo, sham, or control arm. In general, a single-group study can describe observations made among participants exposed to the investigational device. It does not, without a suitable comparison, separate device-related outcomes from other explanations such as participant characteristics, clinical context, or measurement decisions. This design feature is important when interpreting any descriptive result: it is not a randomized estimate of a difference between treatments.

What statistical uncertainty means. In general, an estimate is subject to sampling variability because the participants in a study are one group drawn from a broader population of interest. A confidence interval expresses uncertainty around an estimate under stated modeling assumptions. A wider interval indicates less precision than a narrower interval, while the interval’s interpretation also depends on the design and analysis. The registry record does not report a primary endpoint estimate, confidence interval, or analysis from which the precision of the clinician rating could be evaluated. No uncertainty measure should be inferred from enrollment alone.

In general, a hypothesis test compares observed data with a null hypothesis and produces a p-value under specified assumptions. A p-value does not measure the size or clinical importance of an effect. The registry record lists zero analyses, and it does not report a primary endpoint p-value or a statistical testing plan. It is therefore not possible to identify a reported inferential test for the primary outcome. The absence of a reported p-value should not be recast as evidence for or against the device.

Safety counts and denominators. The adverse-event record lists 61 participants at risk for serious events and 61 at risk for other events. It records zero serious events, zero deaths, and 13 other events. In general, a count describes the number of recorded events or participants meeting an event definition; its interpretation depends on the definition, follow-up, ascertainment, and denominator. The registry record does not provide event terms for the other events or further details of the ascertainment and follow-up in the adverse-event summary. These counts are descriptive and do not provide a comparison with another group.

Planning illustrations. The registry record describes a sample-size illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect; time-to-event illustrations use a total event count, while other illustrations use participants per arm. These assumptions describe planning illustrations, not the actual single-group trial design. They must not be read as the study’s enrollment target, its observed power, or evidence that the trial was designed with two randomized arms. The record does not report the trial’s own sample-size justification. The planning assumptions also do not supply an observed effect in the registry record, so they cannot resolve the missing primary endpoint result.

Over-dispersion in general. For outcomes that are counts, a simple model may assume that variability follows a specified relationship to the mean. Over-dispersion means that the observed variability is greater than that assumed by the model. In general, failing to account for over-dispersion can make standard errors too small and confidence intervals too narrow. The primary outcome in this study is described as a binary participant rating, not a count of repeated events per participant. The registry record does not report a model for the primary outcome or a dispersion assessment. This general concept should not be mistaken for a method reported for this study.

Analysis populations. The primary outcome description identifies an intent-to-treat population for a sensitivity analysis. In general, an intent-to-treat approach seeks to analyze participants according to their original assigned group; that group-based principle is most directly relevant in studies with treatment allocation. This investigation is single-group and lists no allocation. The registry record does not explain how the intent-to-treat population was operationalized, who was included in it, or how the sensitivity analysis was conducted. No analysis result is reported.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Subjects Medically Indicated for a UDS Study")
n      <- c(61)
events <- c(58)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Subjects Medically Indicated for a UDS Study  61  58  95.1  86.3  99.0  86.5  98.3  86.5  98.2

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists six outcome measures, including the primary clinician safety and effectiveness rating and a secondary outcome concerning the percentage of participants free from severe complication for the updated e۰Sense catheters. It lists zero analyses. The record does not describe a multiplicity adjustment, a hierarchy among outcomes, or a strategy for controlling the chance of false-positive findings across multiple statistical tests. Those details are not reported in the registry record.

In general, multiplicity arises when several outcomes, comparisons, time points, or analyses are tested. If each is assessed separately, the chance of at least one nominally positive finding can increase. Prespecified outcome priorities and appropriate methods can help readers understand how multiple results should be interpreted. The registry record does not report a statistical analysis plan that would allow these features to be assessed.

The primary outcome description identifies an intent-to-treat population for a sensitivity analysis, but it does not specify the analysis population in further detail or describe the sensitivity analysis. The registry record does not report how missing outcome data were handled, whether any participants lacked a clinician rating, or whether outcome completeness was assessed. It also does not report a missing-data assumption or method. These omissions prevent evaluation of how missing observations might affect the endpoint result.

Because no primary or secondary outcome analyses are reported, neither multiplicity handling nor missing-data methods can be assessed from the registry record. The stated existence of an intent-to-treat sensitivity population does not establish that the analysis was performed or reveal its result.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The adverse-event record lists 61 participants at risk for serious events and zero serious events. It also lists 61 participants at risk for other events and 13 other events. Deaths are listed as zero. These are the safety counts recorded for subjects medically indicated for a urodynamics study. The registry record does not list the serious-event terms, and it does not provide the terms for the other events in this record.

In general, an adverse-event count is interpreted in relation to how events were defined, collected, and followed. Counts alone do not describe severity beyond the category assigned, timing, duration, relatedness to the device, or whether one participant experienced more than one event. Those details are not reported in the adverse-event summary. The record also does not provide a comparison group, so the counts cannot be compared with events under another device or control condition.

The zero serious events and zero deaths are observed entries in this registry record; they should not be taken as proof that no risk exists. Likewise, the 13 other events are a count, not a judgment about their cause or clinical importance. These safety entries do not report the primary clinician safety and effectiveness rating, which is a separate outcome and is not reported in the registry record.

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

The registry record establishes that a single-group clinical investigation of eSense catheters was completed and that enrollment was 61 participants. It describes a clinician-rated primary outcome intended to assess safety and effectiveness for urodynamic use. It also records zero serious events, zero deaths, and 13 other events. These are the available descriptive details relevant to interpreting the study’s stated questions.

The record does not report the primary outcome result. It therefore does not show how many clinicians rated the catheters safe and effective, how many did not, or how precise any estimate would be. The secondary outcome concerning participants free from severe complication is also listed without a result. The safety counts do not answer either outcome question: serious adverse-event counts and a clinician’s overall binary assessment are distinct measures.

The single-group design does not include a concurrent comparator. Any outcome reported for this group would describe observations in the study participants, not a randomized contrast with another treatment or control. The registry record does not report a statistical analysis of the primary outcome, and it lists zero analyses. No comparative conclusion, inferential result, or estimate of uncertainty can be drawn from the record.

In general, a study’s stated objective and its observed results are different kinds of information. The objective explains what investigators intended to assess; the result shows what was observed under the study’s measurement and analysis procedures. Here, the objective is described, but the primary result is not reported in the registry record. The completed status and enrollment count do not substitute for that missing result.

Accordingly, the record supports a description of the study design and the listed safety counts, but not a conclusion about the primary endpoint or a comparative effect. It also does not provide enough information to assess precision, missing-data impact, or the handling of multiple outcomes.

14. Why This Trial Matters Statistically

This investigation illustrates why a registry record’s outcome definitions and outcome results must be distinguished. The primary outcome is clearly described as a binary clinician rating, and the record explains why clinician feedback was selected: it states that there was no single or combined objective measure from the urodynamics test that could establish safety and effectiveness for the intended use. That rationale helps identify what the study intended to measure, but it does not provide the observed ratings.

For statistical interpretation, the missing result is consequential. Without the number of participants in each rating category, readers cannot describe the observed primary outcome or assess its precision. The record lists six outcome measures and zero analyses, making it especially important not to treat a study objective or a safety count as a substitute for a reported endpoint analysis.

The single-group structure also matters. It identifies this as an investigation of device use without a concurrent control arm. In general, this permits description of experiences in the enrolled group but does not provide a randomized comparison. Recognizing that distinction prevents descriptive safety data from being misread as a comparative estimate.

The safety entries offer some limited descriptive information: zero serious events, zero deaths, and 13 other events are recorded. But those counts do not state what the other events were, and they do not resolve the primary clinician rating. The registry record therefore demonstrates both the value and the limits of registry reporting: design and outcome definitions can be informative, while absent results and analysis details constrain what can be concluded statistically.

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.

A central limitation of interpretation is that the registry record does not report the primary clinician safety and effectiveness rating. It also does not report the result for the listed secondary outcome concerning participants free from severe complication. The record lists six outcome measures and zero analyses, so no reported endpoint estimate, measure of precision, or inferential result is available for assessment.

The study has a single-group design without a comparative, placebo, sham, or control arm. This limits the questions the design can answer: outcomes in the enrolled participants cannot be read as a randomized contrast with another device or control condition. The record does not report a comparison group or comparative analysis.

The primary outcome depends on clinician judgment recorded as a binary response. The registry explains why clinician feedback was used, but the record does not report additional detail about rating procedures, criteria, consistency between clinicians, or how disagreements were handled. The result itself is not reported, so these features cannot be evaluated alongside the ratings.

The registry identifies an intent-to-treat population for a sensitivity analysis but does not define that population further or report the sensitivity analysis. It does not describe missing outcome data, missing-data handling, multiplicity procedures, or a statistical analysis plan. The record also does not report the trial’s sample-size justification. Safety reporting is limited to the listed counts; event terms for the other events and further detail about ascertainment are not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: e۰Sense® Catheter Clinical Investigation — NCT04438499.
• Registry record last updated 2024-12-12; status last verified 2024-11.
• Results first posted 2022-09-07.
• 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

NCT04438499 is a completed, single-group clinical investigation of eSense electronic catheters for urodynamic studies. The registry lists enrollment of 61 participants, Laborie Medical Technologies Inc. as sponsor, and study dates of 2020-06-16 to 2020-12-17. No allocation, masking, or comparative control arm is listed.

The primary outcome was a clinician’s binary safety and effectiveness rating for each subject, with an approximate 60 minutes timeframe. The registry record does not report the primary outcome result or the result of the listed secondary outcome. It lists six outcome measures and zero analyses. Adverse-event entries include zero serious events among 61 participants at risk, zero deaths, and 13 other events among 61 participants at risk.

The record describes the study objective and design but does not provide results sufficient to evaluate the primary endpoint, its precision, or a comparative effect.